Active, not recruitingNCT00565851Updated Dec 30, 2025Results posted

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 3 interventional study of Bevacizumab and Carboplatin in Clear Cell Adenocarcinoma, Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 709 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,052
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases the duration of overall survival in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

II. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

SECONDARY OBJECTIVES:

I. To determine if the addition of bevacizumab to the second-line and maintenance phase of treatment increases the duration of progression-free survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

II. To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity in these patients undergoing retreatment with both agents as first recurrence therapy.

III. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases quality of life (QOL) in patients with recurrent platinum-sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer, as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) trial outcome index and Rand Short Form (SF)-36 physical functioning scale.

IV. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum-sensitive epithelial ovarian, peritoneal primary or fallopian tube cancer.

TRANSLATIONAL RESEARCH OBJECTIVES:

I. To define molecular and biochemical profiles associated with the duration of progression-free survival in platinum-sensitive recurrent ovarian, peritoneal primary or fallopian tube carcinoma treated with combination chemotherapy with or without bevacizumab followed with or without maintenance bevacizumab therapy in the presence or absence of secondary surgical cytoreduction.

II. To identify molecular determinants that predict sensitivity or resistance to carboplatin and paclitaxel with or without bevacizumab followed with or without maintenance bevacizumab therapy.

III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.

OUTLINE: Patients are assigned to 1 of 4 treatment groups. Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking) are eligible to receive chemotherapy after randomization.

Patients who are eligible for surgery undergo abdominal exploration with cytoreduction. Patients are then randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or docetaxel IV over 1 hour and carboplatin IV over 60 minutes on day 1.

ARM II: Patients receive chemotherapy as in Arm I and bevacizumab IV over 30-90 minutes on day 1.

ARM III: Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.

ARM IV: Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.

In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of therapy. Patients with stable disease or partial regression receive a maximum of 8 courses.

Patients without measurable lesions as determined by a computed tomography (CT) scan prior to initiating study treatment continue therapy for 6 courses or, if cancer antigen (CA)-125 normalizes, for 2 courses beyond CA-125 normalization, whichever is greater. Patients in Arm II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

Conditions studied

Clear Cell Adenocarcinoma
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Fallopian Tube Undifferentiated Carcinoma
Mucinous Adenocarcinoma
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinofibroma
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Ovarian Undifferentiated Carcinoma
Primary Peritoneal Clear Cell Adenocarcinoma
Primary Peritoneal Endometrioid Adenocarcinoma
Primary Peritoneal Serous Adenocarcinoma
Primary Peritoneal Transitional Cell Carcinoma
Primary Peritoneal Undifferentiated Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Undifferentiated Carcinoma

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In context

Adenocarcinoma, Clear Cell

83 studies on the registry are indexed under Adenocarcinoma, Clear Cell; 12 are open to participants now.

This study's enrollment of 1,052 is above the median of 44 across 74 interventional studies indexed under Adenocarcinoma, Clear Cell.

Browse Adenocarcinoma, Clear Cell studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization
Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
A complete response to front-line chemotherapy must include: negative physical exam, negative pelvic exam and normalization of CA125, if elevated at baseline; although not required, any radiographic assessment of disease status (e.g. CT, magnetic resonance imaging [MRI], positron emission tomography [PET]/CT, etc) obtained following the completion of primary therapy should be considered negative for disease
All patients must have also had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent (i.e. bevacizumab)
Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy
Patients must have clinically evident recurrent disease for the purpose of this study
Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be more than or equal to 20 mm when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm when measured by spiral CT
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3, equivalent to Common Toxicity Criteria for Adverse Events version (v)4.0 (CTCAE) grade 1
Platelets greater than or equal to 100,000/mm\^3 (CTCAE grade 0-1)
Creatinine (non-isotope dilution mass spectrometry [IDMS]) =\< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
Total bilirubin =\< 1.5 ULN (CTCAE grade 1)
Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =\< 2.5 times the upper limit of normal in the absence of liver metastasis; SGOT/AST \< 5.0 times ULN in the presence of liver metastasis
Alkaline phosphatase =\< 2.5 times the upper limit of normal in the absence of liver metastasis; alkaline phosphatase \< 5.0 times ULN in the presence of liver metastasis
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients must have a urine protein-to-creatinine ratio (UPCR) \< 1.0 mg/dL
This eligibility criterion does not apply to patients enrolled after August 28, 2011; patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization; patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking
Patients must have met the pre-entry requirements as specified
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion criteria

Exclusion Criteria:

Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
Patients receiving concurrent immunotherapy, or radiotherapy
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded
Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed above
Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube, and primary peritoneal) are excluded
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Patients with uncontrolled infection
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
Patients with >= grade 2 peripheral neuropathy
Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds; patients with allergic (hypersensitivity) reactions to these chemotherapeutic agents are NOT excluded IF they were successfully retreated following a desensitization program or protocol
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are nursing are not eligible for this trial; to date, no fetal studies in animal or humans have been performed; the possibility of harm to a fetus is likely; bevacizumab specifically inhibits VEGF, which is responsible for the formation of new blood vessels during development, and antibodies can cross the placenta; therefore, bevacizumab should not be administered to pregnant women; in addition, there are unknown immediate and long-term consequences of chemotherapy administration to these women; in addition, surgical exploration as mandated by randomization during pregnancy may cause imminent mortal consequences; further, it is not known whether bevacizumab is excreted in human milk; because many drugs are excreted in human milk, bevacizumab should not be administered to nursing women; subjects will be apprised of the large potential risk to a developing fetus
Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or a history of stroke within 5 years of the first date of treatment on this study
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with clinically significant cardiovascular disease; this includes:
- Patients with significant cardiac conduction abnormalities, i.e. PR interval > 0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block
- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
- Myocardial infarction, cardiac arrhythmia or unstable angina \< 6 months prior to registration
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Grade II or greater peripheral vascular disease (exception: episodes of ischemia \< 24 hours [hrs] in duration, that are managed non-surgically and without permanent deficit)
- History of cerebrovascular attack (CVA) within six months
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with bevacizumab on cycle #2
Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of 28 days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of 7 days to begin protocol treatment

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,052 participants (actual)

Study arms

Active comparator
Arm I (paclitaxel, docetaxel, carboplatin)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days.
Drug: Carboplatin · Drug: Docetaxel · Other: Laboratory Biomarker Analysis · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Experimental
Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days.
Biological: Bevacizumab · Drug: Carboplatin · Drug: Docetaxel · Other: Laboratory Biomarker Analysis · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Experimental
Arm III (gemcitabine hydrochloride, carboplatin)
Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
Drug: Carboplatin · Drug: Gemcitabine Hydrochloride · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment
Experimental
Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.
Biological: Bevacizumab · Drug: Carboplatin · Drug: Gemcitabine Hydrochloride · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment

Interventions

BiologicalBevacizumab
Given IV
Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev
DrugCarboplatin
Given IV
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
DrugDocetaxel
Given IV
Also known as: Docecad, RP 56976, RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate
DrugGemcitabine Hydrochloride
Given IV
Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011
OtherLaboratory Biomarker Analysis
Correlative studies
DrugPaclitaxel
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment

What researchers measure

Primary outcomes

To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Time frame: The time frame is 82.5 months (median duration of follow-up)
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Time frame: The time frame is 82.5 months (median duration of follow-up).

Secondary outcomes

Progression-free Survival (Chemotherapy Analysis)
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
Time frame: Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase
Progression Free Survival (Surgery Analysis)
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
Time frame: Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.
Summary of Adverse Events (CTCAE Version 4.0)
Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
Time frame: During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
Patient Reported Quality of Life (Chemotherapy Analysis)
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Time frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Patient Reported Physical Function (Chemotherapy Analysis)
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.
Time frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Patient Reported Quality of Life (Surgery Analysis)
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Time frame: 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
Patient Reported Physical Functioning (Surgery Analysis)
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.
Time frame: 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery

Results

Posted Dec 14, 2020

Participant flow

At the beginning of the study participants could be randomized to chemotherapy. On August 29, 2011 randomization to chemotherapy ended and participants could only be randomized to surgery.

Surgical Assignment

Participant flow — Surgical Assignment
Milestone	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Started	316	456	33	165	6	34	5	37
Randomized - yes surgery	0	0	33	165	0	0	5	37
Randomized - no surgery	33	172	0	0	6	34	0	0
Not surgical candidate	283	284	0	0	0	0	0	0
Completed	313	454	31	154	6	34	5	35
Not completed	3	2	2	11	0	0	0	2

Chemotherapy Assignment

Participant flow — Chemotherapy Assignment
Milestone	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Started	316	456	33	165	6	34	5	37
Randomized to chemo	310	311	27	26	0	0	0	0
Pre-specified chemo	6	145	6	139	6	34	5	37
Completed	307	433	30	129	6	31	5	34
Not completed	9	23	3	36	0	3	0	3
Withdrew: Never initiated chemotherapy	9	9	3	18	0	2	0	2
Withdrew: Still on chemotherapy	0	14	0	18	0	1	0	1

Outcome measures

PrimaryTo Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer

The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.

Time frame:: The time frame is 82.5 months (median duration of follow-up)
Reported as:: Median · Months

To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
Months	No Cytoreductive Surgery	Cytoreductive Surgery
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer	64.7 (54.5 to 73.9)	50.6 (44.2 to 59.7)

PrimaryTo Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer

Time frame:: The time frame is 82.5 months (median duration of follow-up).
Reported as:: Median · Months

To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
Months	Paclitaxel and Carboplatin Chemotherapy	Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer	37.3 (32.6 to 39.7)	42.2 (37.7 to 46.2)

SecondaryProgression-free Survival (Chemotherapy Analysis)

Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.

Time frame:: Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase
Reported as:: Median · Months

Progression-free Survival (Chemotherapy Analysis)
Months	Paclitaxel and Carboplatin Chemotherapy	Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Progression-free Survival (Chemotherapy Analysis)	10.4 (9.7 to 11.0)	13.8 (13.0 to 14.7)

SecondaryProgression Free Survival (Surgery Analysis)

Time frame:: Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.
Reported as:: Median · Months

Progression Free Survival (Surgery Analysis)
Months	No Cytoreductive Surgery	Cytoreductive Surgery
Progression Free Survival (Surgery Analysis)	16.2 (14.2 to 19.6)	18.9 (16.8 to 21.0)

SecondarySummary of Adverse Events (CTCAE Version 4.0)

Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))

Time frame:: During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
Reported as:: Count of participants · Participants

Summary of Adverse Events (CTCAE Version 4.0)
Participants	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Summary of Adverse Events (CTCAE Version 4.0)	304	376	29	77	3	9	3	9

SecondaryPatient Reported Quality of Life (Chemotherapy Analysis)

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.

Time frame:: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Reported as:: Least squares mean · score on a scale

Patient Reported Quality of Life (Chemotherapy Analysis)
score on a scale	Paclitaxel and Carboplatin Chemotherapy	Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Prior to cycle 1 (baseline)	75.8 ± 0.8	75.3 ± 0.9
Prior to cycle 3	74.2 ± 1.0	73.4 ± 0.9
Prior to cycle 6	73.3 ± 1.0	72.3 ± 1.0
6 months post cycle 1	77.1 ± 1.0	77.2 ± 1.0
12 months post cycle 1	77.0 ± 1.1	77.8 ± 1.0

SecondaryPatient Reported Physical Function (Chemotherapy Analysis)

Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.

Time frame:: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Reported as:: Least squares mean · score on a scale

Patient Reported Physical Function (Chemotherapy Analysis)
score on a scale	Paclitaxel and Carboplatin Chemotherapy	Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Prior to cycle 1 (baseline)	71.5 ± 1.6	69.4 ± 1.7
Prior to cycle 3	73.2 ± 2.1	69.8 ± 2.1
Prior to cycle 6	71.5 ± 2.2	64.6 ± 2.2
6 months post cycle 1	71.6 ± 2.2	70.2 ± 2.1
12 months post cycle 1	71.8 ± 2.2	70.7 ± 2.2

SecondaryPatient Reported Quality of Life (Surgery Analysis)

Time frame:: 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
Reported as:: Least squares mean · score on a scale

Patient Reported Quality of Life (Surgery Analysis)
score on a scale	No Cytoreductive Surgery	Cytoreductive Surgery
Prior to surgery	74.5 ± 1.0	74.2 ± 1.0
6 weeks post-surgery	69.3 ± 1.3	68.4 ± 1.3
15 weeks post-surgery	68.7 ± 1.3	68.8 ± 1.3
6 months post-surgery	72.6 ± 1.3	73.5 ± 1.3
12 months post-surgery	74.0 ± 1.4	75.6 ± 1.3

SecondaryPatient Reported Physical Functioning (Surgery Analysis)

Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.

Time frame:: 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery
Reported as:: Least squares mean · score on a scale

Patient Reported Physical Functioning (Surgery Analysis)
score on a scale	No Cytoreductive Surgery	Cytoreductive Surgery
Prior to surgery (baseline)	73.4 ± 2.3	71.7 ± 2.3
6 weeks post-surgery	73.2 ± 2.1	69.8 ± 2.1
15 weeks post-surgery	71.5 ± 2.2	64.6 ± 2.2
6 months post-surgery	71.6 ± 2.2	70.2 ± 2.1
12 months post-surgery	71.8 ± 2.2	70.7 ± 2.2

Adverse events

Collected over During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm I (no Surgery; Carboplatin and Paclitaxel)	253/316 (80.1%)	37/316 (11.7%)	304/316 (96.2%)
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	299/456 (65.6%)	104/456 (22.8%)	376/456 (82.5%)
Arm III (Surgery; Carboplatin and Paclitaxel)	28/33 (84.8%)	1/33 (3%)	29/33 (87.9%)
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	56/165 (33.9%)	24/165 (14.5%)	77/165 (46.7%)
Arm V (no Surgery; Carboplatin and Gemcitabine)	4/6 (66.7%)	0/6 (0%)	3/6 (50%)
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)	14/34 (41.2%)	1/34 (2.9%)	9/34 (26.5%)
Arm VII (Surgery; Carboplatin and Gemcitabine)	4/5 (80%)	2/5 (40%)	3/5 (60%)
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)	21/37 (56.8%)	2/37 (5.4%)	9/37 (24.3%)

Most frequent serious events

Showing 10 of 88

Most frequent serious events
Event	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Allergic Reaction/HypersensitivityImmune system disorders	1/316	8/456	0/33	2/165	0/6	0/34	1/5	0/37
Obstruction, Gi - ColonGastrointestinal disorders	0/316	0/456	0/33	1/165	0/6	0/34	1/5	0/37
Febrile NeutropeniaInfections and infestations	7/316	14/456	0/33	3/165	0/6	0/34	0/5	0/37
Infection - OtherInfections and infestations	0/316	1/456	1/33	0/165	0/6	0/34	0/5	0/37
Thrombosis/Thrombus/EmbolismVascular disorders	4/316	6/456	0/33	1/165	0/6	1/34	0/5	0/37
Perforation, Gi - ColonGastrointestinal disorders	0/316	1/456	0/33	0/165	0/6	0/34	0/5	1/37
Inf Unknown Anc: Catheter-RelatedInfections and infestations	0/316	1/456	0/33	0/165	0/6	0/34	0/5	1/37
Obstruction, Gi - Small Bowel NosGastrointestinal disorders	1/316	6/456	0/33	1/165	0/6	0/34	0/5	0/37
Pain: Abdominal Pain NosGeneral disorders	0/316	5/456	0/33	0/165	0/6	0/34	0/5	0/37
NeutrophilsBlood and lymphatic system disorders	3/316	4/456	0/33	1/165	0/6	0/34	0/5	0/37

Most frequent other events

Showing 10 of 370

Most frequent other events
Event	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
NeutrophilsBlood and lymphatic system disorders	282/316	363/456	28/33	72/165	3/6	7/34	3/5	8/37
HemoglobinBlood and lymphatic system disorders	279/316	316/456	29/33	67/165	3/6	9/34	3/5	9/37
LeukocytesBlood and lymphatic system disorders	276/316	350/456	28/33	67/165	3/6	9/34	3/5	9/37
FatigueGeneral disorders	245/316	297/456	25/33	48/165	2/6	5/34	3/5	5/37
Hair Loss/Alopecia (Scalp Or Body)Skin and subcutaneous tissue disorders	245/316	289/456	21/33	47/165	2/6	3/34	1/5	2/37
Neuropathy-SensoryNervous system disorders	237/316	272/456	18/33	55/165	3/6	4/34	1/5	5/37
PlateletsBlood and lymphatic system disorders	173/316	264/456	22/33	52/165	3/6	7/34	3/5	8/37
ConstipationGastrointestinal disorders	167/316	193/456	20/33	39/165	2/6	2/34	1/5	3/37
NauseaGastrointestinal disorders	182/316	223/456	19/33	42/165	1/6	3/34	1/5	6/37
Pain: Abdominal Pain NosGeneral disorders	84/316	127/456	16/33	36/165	2/6	2/34	1/5	4/37

Baseline characteristics

All patients enrolled

Age, Continuous
Age, Continuous(years)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
Mean	60.9 ± 10.0	59.0 ± 10.3	58.7 ± 10.0	57.1 ± 10.5	72.1 ± 7.4	58.7 ± 8.2	60.7 ± 9.3	61.1 ± 9.5	59.4 ± 10.2

Age, Customized
Age, Customized(Participants)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
< 40 years	4	14	0	7	0	0	0	0	25
40 - 49 years	40	68	6	37	0	6	1	6	164
50 - 59 years	102	170	11	57	1	14	1	9	365
60 - 69 years	111	143	10	44	0	12	2	13	335
70 - 79 years	52	54	6	19	5	2	1	9	148
≥ 80 years	7	7	0	1	0	0	0	0	15

Sex: Female, Male
Sex: Female, Male(Participants)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
Female	316	456	33	165	6	34	5	37	1052
Male	0	0	0	0	0	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
Hispanic or Latino	14	22	0	6	0	0	0	4	46
Not Hispanic or Latino	272	409	30	155	6	34	5	32	943
Unknown or Not Reported	30	25	3	4	0	0	0	1	63

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
American Indian or Alaska Native	1	5	0	0	0	0	0	0	6
Asian	39	136	6	101	0	14	1	10	307
Native Hawaiian or Other Pacific Islander	0	1	0	0	0	0	0	0	1
Black or African American	15	17	1	4	1	3	1	2	44
White	255	294	26	57	5	17	3	25	682
More than one race	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	6	3	0	3	0	0	0	0	12

Region of Enrollment
Region of Enrollment(Participants)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
South Korea	20	108	4	90	0	11	0	9	242
United States	284	324	29	67	6	23	5	28	766
Japan	12	24	0	7	0	0	0	0	43
Russia	0	0	0	1	0	0	0	0	1

Histology
Histology(Participants)	Arm I (no Surgery; Carboplatin and Paclitaxel)	Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm III (Surgery; Carboplatin and Paclitaxel)	Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)	Arm V (no Surgery; Carboplatin and Gemcitabine)	Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Arm VII (Surgery; Carboplatin and Gemcitabine)	Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))	Total
Serous	252	383	30	142	5	30	4	35	881
Endometrioid	25	24	0	9	1	2	0	2	63
Clear Cell	13	14	1	5	0	0	0	0	33
Mucinous	2	2	0	0	0	0	0	0	4
Other	24	33	2	9	0	2	1	0	71

Study locations

709 sites

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Regional Hospital
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913, United States
Sutter Auburn Faith Hospital
Auburn, California 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
Mills-Peninsula Medical Center
Burlingame, California 94010, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California 95682, United States
John Muir Medical Center-Concord
Concord, California 94520, United States
Sutter Davis Hospital
Davis, California 95616, United States
UC San Diego Moores Cancer Center
La Jolla, California 92093, United States
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California 90806, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095, United States
Memorial Medical Center
Modesto, California 95355, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California 94040, United States
Sutter Cancer Research Consortium
Novato, California 94945, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661, United States
Sutter Roseville Medical Center
Roseville, California 95661, United States
Sutter Medical Center Sacramento
Sacramento, California 95816, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115, United States
UCSF Medical Center-Mount Zion
San Francisco, California 94115, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065, United States
Sutter Pacific Medical Foundation
Santa Rosa, California 95403, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012, United States
The Medical Center of Aurora
Aurora, Colorado 80012, United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045, United States
Boulder Community Foothills Hospital
Boulder, Colorado 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907, United States
AdventHealth Porter
Denver, Colorado 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220, United States
Rose Medical Center
Denver, Colorado 80220, United States
Western States Cancer Research NCORP
Denver, Colorado 80222, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado 81301, United States
Mercy Medical Center
Durango, Colorado 81301, United States
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado 80110, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113, United States
Swedish Medical Center
Englewood, Colorado 80113, United States
Mountain Blue Cancer Care Center
Golden, Colorado 80401, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501, United States
Banner North Colorado Medical Center
Greeley, Colorado 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado 80111, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228, United States
Saint Anthony Hospital
Lakewood, Colorado 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120, United States
AdventHealth Littleton
Littleton, Colorado 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado 80124, United States
Longmont United Hospital
Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado 80539, United States
AdventHealth Parker
Parker, Colorado 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado 81008, United States
North Suburban Medical Center
Thornton, Colorado 80229, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado 80401, United States
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut 06606, United States
University of Connecticut
Farmington, Connecticut 06030, United States
Hartford Hospital
Hartford, Connecticut 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105, United States
Middlesex Hospital
Middletown, Connecticut 06457, United States
The Hospital of Central Connecticut
New Britain, Connecticut 06050, United States
Beebe Medical Center
Lewes, Delaware 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713, United States
Helen F Graham Cancer Center
Newark, Delaware 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware 19973, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010, United States
AdventHealth Altamonte
Altamonte Springs, Florida 32701, United States
GenesisCare USA - FGO
Fort Myers, Florida 33905, United States
AdventHealth Kissimmee
Kissimmee, Florida 34744, United States
AdventHealth Medical Group Urology at Orlando
Orlando, Florida 32803, United States
AdventHealth Orlando
Orlando, Florida 32803, United States
AdventHealth East Orlando
Orlando, Florida 32822, United States

Showing the first 100 of 709 sites across 3 countries.

References and documents

Publications

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PubMed 37185961 ↗
Coleman RL, Spirtos NM, Enserro D, Herzog TJ, Sabbatini P, Armstrong DK, Kim JW, Park SY, Kim BG, Nam JH, Fujiwara K, Walker JL, Casey AC, Alvarez Secord A, Rubin S, Chan JK, DiSilvestro P, Davidson SA, Cohn DE, Tewari KS, Basen-Engquist K, Huang HQ, Brady MF, Mannel RS. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer. N Engl J Med. 2019 Nov 14;381(20):1929-1939. doi: 10.1056/NEJMoa1902626. PubMed 31722153 ↗
Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21. PubMed 28438473 ↗

Study documents

Protocol and statistical analysis plan · Nov 16, 2018

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00565851
Lead sponsor: National Cancer Institute (NCI)
Collaborators: NRG Oncology
Responsible party: Sponsor
First posted: Nov 30, 2007
Start date: Dec 6, 2007
Primary completion: Apr 30, 2019
Completion: Jan 1, 2028 (estimated)
Results posted: Dec 14, 2020
Last update: Dec 30, 2025

Study contacts

Robert L Coleman

principal investigator · NRG Oncology

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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