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Status unknownNCT00492778Updated Mar 29, 2023Results posted

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

A Phase 2 interventional study of 3-Dimensional Conformal Radiation Therapy and Cisplatin in Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Mucinous Adenocarcinoma and Endometrial Squamous Cell Carcinoma, sponsored by GOG Foundation. Status unknown at 441 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by GOG Foundation · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Sex
Female
01

Study summary

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.

SECONDARY OBJECTIVES:

I. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.

II. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.

III. To estimate the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.

IV. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate interstitial brachytherapy*.

ARM II: Patients undergo EBRT as in Arm I and receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy* as in Arm I.

NOTE: *IMRT boost is allowed for patients who are not candidates for brachytherapy. IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis and/or the boost in patients not undergoing brachytherapy. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

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

02

Conditions studied

  • Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
  • Endometrial Mucinous Adenocarcinoma
  • Endometrial Squamous Cell Carcinoma
  • Recurrent Endometrial Clear Cell Adenocarcinoma
  • Recurrent Endometrial Endometrioid Adenocarcinoma
  • Recurrent Endometrial Serous Adenocarcinoma
  • Recurrent Endometrial Undifferentiated Carcinoma
  • Recurrent Uterine Corpus Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 165 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

GOG Foundation is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma
  • Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease
  • Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
  • Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done

  • Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina

    • Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible
  • Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
  • Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
  • Patients must have an estimated survival greater or equal to 3 months
  • Absolute neutrophil count (ANC) >= 1,500/mm\^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1
  • Platelets >= 100,000/mm\^3 (CTCAE v 3.0 grade 0-1)
  • Creatinine =\< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min
  • Bilirubin =\< 1.5 x ULN (CTCAE v 3.0 grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
  • Alkaline phosphatase =\< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
  • Neuropathy (sensory and motor) =\< CTCAE v 3.0 grade 1
  • Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
  • Patients who have met the pre-entry requirements
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion criteria

Exclusion Criteria:

  • Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes
  • Patients who have received previous vaginal, pelvic, or abdominal irradiation
  • Patients who received chemotherapy directed at the present recurrence
  • Patients with septicemia or severe infection
  • Patients who have circumstances that will not permit completion of this study or the required follow-up
  • Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection
  • Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration
  • Patients with history of active collagen vascular disease
  • Patients with GOG performance grade of 3 or 4
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    Arm I (brachytherapy, radiation therapy)

    Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.

    Radiation: 3-Dimensional Conformal Radiation Therapy · Radiation: Intensity-Modulated Radiation Therapy · Radiation: Internal Radiation Therapy

  • Experimental
    Arm II (brachytherapy, radiation therapy, cisplatin)

    Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.

    Radiation: 3-Dimensional Conformal Radiation Therapy · Drug: Cisplatin · Radiation: Intensity-Modulated Radiation Therapy · Radiation: Internal Radiation Therapy

Interventions

  • Radiation3-Dimensional Conformal Radiation Therapy

    Undergo 3-dimensional conformal radiation therapy

    Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal

  • DrugCisplatin

    Given IV

    Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

  • RadiationIntensity-Modulated Radiation Therapy

    Undergo IMRT

    Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

  • RadiationInternal Radiation Therapy

    Given intracavitarily or interstitially

    Also known as: Brachytherapy, Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy, Radiation, Internal

06

What researchers measure

Primary outcomes

  1. Number of Participants With Disease Progression or Death.

    The number of participants with disease progression or death from study entry to progression or death. Participants who experienced progression or death were reported by treatment arm.

    Time frame: Median follow-up for progression-free survival was 62 months with a maximum of 128 months. Patients were followed from study entry until disease progression, death, or date of last contact

Secondary outcomes

  1. Number of Participants That Experienced Death on Study

    Overall survival is the period from study entry until death or date of last contact. The treatment regimens were compared with regard to overall survival.

    Time frame: Participants were followed from study entry until death or date of last contact. Median follow-up for overall survival was 62 months with a maximum of 128 months.

  2. Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.

    Participants were put in prognostic groups including baseline factors of tumor location (vagina only vs. all others) and histology (serious and clear cell vs. all others). They were assessed for prognostic associations with progression-free survival. Participant factors were collected at baseline. Participants were followed from study entry until disease progression, death, or date of last contact for progression-free survival.

    Time frame: Median follow-up for progression-free survival was 62 months with a maximum of 128 months.

  3. Number of Participants That Experienced Adverse Effects Grade 3 or Higher

    Number of treated participants with adverse events of grade 3 or higher. Graded by Common Terminology Criteria for Adverse Events version 3.0. Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years.

    Time frame: Maximum follow-up for adverse events was 61 months.

07

Results

Posted Mar 29, 2023

Participant flow

Enrollment onto this study began February 25, 2008. Enrollment of the study ended August 12, 2020 after 165 patients had been enrolled.

Participant flow — Overall Study
MilestoneArm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)
Started8283
Completed7482
Not completed81
Withdrew: Ineligible by pathology review81

Outcome measures

PrimaryNumber of Participants With Disease Progression or Death.

The number of participants with disease progression or death from study entry to progression or death. Participants who experienced progression or death were reported by treatment arm.

Time frame:
Median follow-up for progression-free survival was 62 months with a maximum of 128 months. Patients were followed from study entry until disease progression, death, or date of last contact
Reported as:
Count of participants · Participants
Number of Participants With Disease Progression or Death.
ParticipantsArm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)
Number of Participants With Disease Progression or Death.2735
SecondaryNumber of Participants That Experienced Death on Study

Overall survival is the period from study entry until death or date of last contact. The treatment regimens were compared with regard to overall survival.

Time frame:
Participants were followed from study entry until death or date of last contact. Median follow-up for overall survival was 62 months with a maximum of 128 months.
Reported as:
Count of participants · Participants
Number of Participants That Experienced Death on Study
ParticipantsArm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)
Number of Participants That Experienced Death on Study1821
SecondaryNumber of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.

Participants were put in prognostic groups including baseline factors of tumor location (vagina only vs. all others) and histology (serious and clear cell vs. all others). They were assessed for prognostic associations with progression-free survival. Participant factors were collected at baseline. Participants were followed from study entry until disease progression, death, or date of last contact for progression-free survival.

Time frame:
Median follow-up for progression-free survival was 62 months with a maximum of 128 months.
Reported as:
Count of participants · Participants
Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.
ParticipantsPrognostic Group 1Prognostic Group 2Prognostic Group 3Prognostic Group 4
Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.454013
SecondaryNumber of Participants That Experienced Adverse Effects Grade 3 or Higher

Number of treated participants with adverse events of grade 3 or higher. Graded by Common Terminology Criteria for Adverse Events version 3.0. Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years.

Time frame:
Maximum follow-up for adverse events was 61 months.
Reported as:
Count of participants · Participants
Number of Participants That Experienced Adverse Effects Grade 3 or Higher
ParticipantsTreated Regimen ITreated Regimen II
Number of Participants That Experienced Adverse Effects Grade 3 or Higher3749

Adverse events

Collected over Treated patients were evaluated for adverse events during the treatment period, every month for the first three months after completion of therapy up to 2 years, and then every six months for the next 3 years. Maximum follow-up for adverse events was 61 months. Deaths were reported up to 5 years after study treatment discontinuation. Median follow up for overall survival was 62 months with a maximum of 128 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Brachytherapy, Radiation Therapy)18/74 (24.3%)3/74 (4.1%)72/74 (97.3%)
Arm II (Brachytherapy, Radiation Therapy, Cisplatin)21/82 (25.6%)12/82 (14.6%)76/82 (92.7%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventArm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)
Thrombosis/Thrombus/EmbolismVascular disorders0/743/82
DiarrheaGastrointestinal disorders2/740/82
Conduction Abnml: AsystoleCardiac disorders1/740/82
ColitisGastrointestinal disorders1/740/82
Allergic Reaction/HypersensitivityImmune system disorders0/741/82
Cardiac Ischemia/InfarctionCardiac disorders0/741/82
HypotensionCardiac disorders0/741/82
Fistula, Gi - Small Bowel NosGastrointestinal disorders0/741/82
VomitingGastrointestinal disorders0/741/82
Hemorrhage, Gi - EsophagusVascular disorders0/741/82
Most frequent other events
Showing 10 of 230
Most frequent other events
EventArm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)
DiarrheaGastrointestinal disorders62/7465/82
FatigueGeneral disorders52/7464/82
LeukocytesBlood and lymphatic system disorders34/7461/82
NauseaGastrointestinal disorders28/7453/82
HemoglobinBlood and lymphatic system disorders27/7450/82
PlateletsBlood and lymphatic system disorders22/7447/82
NeutrophilsBlood and lymphatic system disorders6/7437/82
ConstipationGastrointestinal disorders21/7429/82
HypomagnesemiaMetabolism and nutrition disorders9/7429/82
Pain: Abdominal Pain NosGeneral disorders26/7414/82

Baseline characteristics

Eligible and Evaluable

Age, Customized
Age, Customized(Participants)Arm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)Total
< 60 years161935
60-80 years4959108
> 80 years9413
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)Total
Female7482156
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)Total
Hispanic or Latino4610
Not Hispanic or Latino6574139
Unknown or Not Reported527
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)Total
American Indian or Alaska Native011
Asian033
Native Hawaiian or Other Pacific Islander123
Black or African American516
White6574139
More than one race000
Unknown or Not Reported314
Tumor Location
Tumor Location(Participants)Arm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)Total
Both pelvis and vagina4711
Pelvis only7411
Vagina only6371134
Histology
Histology(Participants)Arm I (Brachytherapy, Radiation Therapy)Arm II (Brachytherapy, Radiation Therapy, Cisplatin)Total
Endometrioid, grade 1 - usually considered non-aggressive and have the most favorable outcome.484290
Endometrioid, grade 2 - more likely to spread outside the uterus. Worse outcome than grade 1.162238
Endometrioid, grade 3 - usually more aggressive with a worse outcome than lower grade tumors.2810
Endometrioid, grade unknown101
Serous246
Clear Cell101
Mixed Epithelial325
Adenocarcinoma, not specified134
Other011
08

Study locations

441 sites
  • 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
  • Eden Hospital Medical Center
    Castro Valley, California 94546, United States
  • Sutter Davis Hospital
    Davis, California 95616, United States
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, 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
  • 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
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • University of California San Diego
    San Diego, California 92103, United States
  • California Pacific Medical Center-Pacific Campus
    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
  • Olive View-University of California Los Angeles Medical Center
    Sylmar, California 91342, United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
    Vacaville, California 95687, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California 94589, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
  • Beebe Medical Center
    Lewes, Delaware 19958, United States
  • Christiana Gynecologic Oncology LLC
    Newark, Delaware 19713, 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
  • Sibley Memorial Hospital
    Washington, District of Columbia 20016, United States
  • Sarasota Memorial Hospital
    Sarasota, Florida 34239, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Augusta University Medical Center
    Augusta, Georgia 30912, United States
  • Northeast Georgia Medical Center-Gainesville
    Gainesville, Georgia 30501, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    Savannah, Georgia 31405, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
  • Walter Knox Memorial Hospital
    Emmett, Idaho 83617, United States
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
  • Saint Alphonsus Medical Center-Nampa
    Nampa, Idaho 83686, United States
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
  • Kootenai Cancer Clinic
    Sandpoint, Idaho 83864, United States
  • Rush - Copley Medical Center
    Aurora, Illinois 60504, United States
  • Saint Joseph Medical Center
    Bloomington, Illinois 61701, United States
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
  • NorthShore University HealthSystem-Evanston Hospital
    Evanston, Illinois 60201, United States
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
  • Western Illinois Cancer Treatment Center
    Galesburg, Illinois 61401, United States
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
  • Sudarshan K Sharma MD Limited-Gynecologic Oncology
    Hinsdale, Illinois 60521, United States
  • Duly Health and Care Joliet
    Joliet, Illinois 60435, United States
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Garneau, Stewart C MD (UIA Investigator)
    Moline, Illinois 61265, United States
  • Spector, David MD (UIA Investigator)
    Moline, Illinois 61265, United States
  • Trinity Medical Center
    Moline, Illinois 61265, United States
  • Illinois CancerCare-Monmouth
    Monmouth, Illinois 61462, United States
  • Bromenn Regional Medical Center
    Normal, Illinois 61761, United States
  • Carle Cancer Institute Normal
    Normal, Illinois 61761, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453-2699, United States
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States
  • Ottawa Regional Hospital and Healthcare Center
    Ottawa, Illinois 61350, United States
  • Illinois CancerCare-Pekin
    Pekin, Illinois 61554, United States
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
    Pekin, Illinois 61554, United States
  • Illinois CancerCare-Peoria
    Peoria, Illinois 61615, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
    Peoria, Illinois 61615, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61636, United States
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • Illinois CancerCare-Peru
    Peru, Illinois 61354, United States
  • Valley Radiation Oncology
    Peru, Illinois 61354, United States
  • Illinois CancerCare-Princeton
    Princeton, Illinois 61356, United States
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois 60555, United States
  • Parkview Hospital Randallia
    Fort Wayne, Indiana 46805, United States
  • Parkview Regional Medical Center
    Fort Wayne, Indiana 46845, United States
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Franciscan Saint Anthony Health-Michigan City
    Michigan City, Indiana 46360, United States
  • Memorial Regional Cancer Center Day Road
    Mishawaka, Indiana 46545, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States

Showing the first 100 of 441 sites across 2 countries.

09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 21, 2014

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00492778
Lead sponsor
GOG Foundation
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 27, 2007
Start date
Feb 25, 2008
Primary completion
Dec 15, 2021
Results posted
Mar 29, 2023
Last update
Mar 29, 2023

Study contacts

Jonathan M Feddock
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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