CClinicalTrials.gg
CompletedNCT01039207Updated Sep 7, 2017Results posted

Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 2 interventional study of Laboratory Biomarker Analysis and Rilotumumab in Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by Gynecologic Oncology Group. Completed at 28 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This phase II trial studies how well rilotumumab works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has failed to respond to other therapies (persistent) or has returned after a period of improvement (recurrent). Rilotumumab is a type of drug called a monoclonal antibody, and may interfere with the ability of tumor cells to grow and spread by targeting certain cells and blocking them from working.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events associated with treatment with AMG 102 (rilotumumab) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

II. To determine the duration of progression-free survival (PFS) and overall survival (OS).

TERTIARY OBJECTIVES:

I. To explore the association between a panel of biomarkers (as assayed by immunohistochemistry and mutation analysis) and measures of response to treatment with AMG 102 (rilotumumab) and clinical outcome in archived tumor tissue.

II. To evaluate circulating pre- and post-treatment levels of hepatocyte growth factor/scatter factor and markers of angiogenesis and their association with response to treatment with AMG 102 (rilotumumab) and clinical outcome.

OUTLINE:

Patients receive rilotumumab intravenously (IV) over 30-60 minutes on days 1 and 14. Courses repeat every 4 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 and then every 6 months for 3 years.

02

Conditions studied

  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 31 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic confirmation of the original primary tumor is required via the pathology report
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol for the same patient population
  • Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2

    • Patients who have received two prior regimens must have a GOG performance status of 0 or 1
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Major surgical procedures must have taken place > 30 days before enrollment; minor surgical procedures must have taken place > 14 days before enrollment; central venous catheter placement is allowed at any time prior to enrollment provided the patient has recovered and any surgical would has healed
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infections [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:

    • Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa

      • Note: Patients on this non-cytotoxic study are allowed to have received prior cytotoxic chemotherapy for management of recurrent or persistent disease, as defined above; however, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
  • Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
  • Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease; patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Hemoglobin >= 9 g/dL
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • PTT (partial thromboplastin time) =\< 1.5 x ULN
  • International normalized ratio (INR) =\< 1.5 x ULN
  • Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
  • Proteinuria: =\< 1+ (urinalysis) or \< 1 g/24 hrs (24 hour urine collection)
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception

Exclusion criteria

Exclusion Criteria:

  • Patients who have had previous treatment with AMG 102 (rilotumumab) or other hepatocyte growth factor (HGF)/MET proto-oncogene, receptor tyrosine kinase (c-met) pathway inhibitors
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients with 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 an active bleeding diathesis or on concurrent or prior (within 7 days of enrollment) therapeutic anti-coagulation therapy with warfarin, heparin, or low molecular weight heparin; the use of low-dose warfarin (=\< 2 mg orally [PO] daily) for prophylaxis against central venous catheter thrombosis is allowed
  • Patients with serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this treatment
  • Patients who are pregnant or breastfeeding
  • Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol
  • Patients with a serious or non-healing wound
  • Patients with peripheral edema or lymphedema > grade 2
  • Patients with known positive human immunodeficiency virus (HIV) or hepatitis C or chronic or active hepatitis B
  • Patients with thromboembolic event or ischemic event within the past 12 months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Treatment (rilotumumab)

    Patients receive rilotumumab IV over 30-60 minutes on days 1 and 14. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Tumor tissue and blood samples may be collected periodically for further laboratory analysis.

    Other: Laboratory Biomarker Analysis · Biological: Rilotumumab

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalRilotumumab

    Given IV

    Also known as: AMG 102, Anti-HGF Monoclonal Antibody AMG 102, Fully Human Anti-HGF Monoclonal Antibody AMG 102

06

What researchers measure

Primary outcomes

  1. Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1

    Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

    Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.

  2. Progression-free Survival > 6 Months Using RECIST 1.0

    Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

    Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.

Secondary outcomes

  1. Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0

    Number of participants with a maximum grade of 3 or higher during the treatment period.

    Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment

  2. Duration of Overall Survival (OS)

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Time frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

  3. Duration of Progression-free Survival (PFS)

    Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

    Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.

Other outcomes

  1. Biomarker Panel From Tumor Tissue

    A panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.

    Time frame: Baseline

  2. Circulating Levels of HGF/Scatter Factor (SF)

    Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).

    Time frame: Up to 1 day prior to course 2

  3. Circulating Levels of Markers of Angiogenesis

    Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).

    Time frame: Up to 1 day prior to course 2

07

Results

Posted Sep 7, 2017

Participant flow

This trial was opened to patient entry on October 10, 2010 and was closed to accrual on May 10, 2011.

Participant flow — Overall Study
MilestoneAMG 102
Started31
Completed31
Not completed0

Outcome measures

PrimaryProportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1

Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Time frame:
CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.
Reported as:
Number · participants
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
participantsAMG 102
Partial response0
Complete response1
PrimaryProgression-free Survival > 6 Months Using RECIST 1.0

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

Time frame:
CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.
Reported as:
Number · participants
Progression-free Survival > 6 Months Using RECIST 1.0
participantsAMG 102
Patient with PFS>6 Months2
Patients with PFS<6 months29
SecondaryIncidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0

Number of participants with a maximum grade of 3 or higher during the treatment period.

Time frame:
Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Reported as:
Number · participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
participantsAMG 102
Leukopenia1
Neutropenia1
Cardiac1
Nausea2
Vomiting4
Other Gastrointestinal7
General and administration site4
Hepatobiliary1
Infections/infestations2
Metabolism/nutrition5
Respiratory/thoracic/mediastinal1
Skin/subcutaneous1
Vascular disorders2
SecondaryDuration of Overall Survival (OS)

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Time frame:
Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Reported as:
Number · months
Duration of Overall Survival (OS)
monthsAMG 102
Duration of Overall Survival (OS)4.3 (1.9 to 5.8)
SecondaryDuration of Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

Time frame:
CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.
Reported as:
Median · months
Duration of Progression-free Survival (PFS)
monthsAMG 102
Duration of Progression-free Survival (PFS)1.8 (1.7 to 1.9)
Other pre-specifiedBiomarker Panel From Tumor Tissue

A panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.

Time frame:
Baseline

Results for this outcome have not been posted.

Other pre-specifiedCirculating Levels of HGF/Scatter Factor (SF)

Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).

Time frame:
Up to 1 day prior to course 2

Results for this outcome have not been posted.

Other pre-specifiedCirculating Levels of Markers of Angiogenesis

Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).

Time frame:
Up to 1 day prior to course 2

Results for this outcome have not been posted.

Adverse events

Collected over Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AMG 10214/31 (45.2%)14/31 (45.2%)31/31 (100%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventAMG 102
VomitingGastrointestinal disorders3/31
Abdominal PainGastrointestinal disorders3/31
Death NosGeneral disorders3/31
Pleural EffusionRespiratory, thoracic and mediastinal disorders2/31
DiarrheaGastrointestinal disorders1/31
Small Intestinal ObstructionGastrointestinal disorders1/31
Gastrointestinal Disorders - OtherGastrointestinal disorders1/31
AscitesGastrointestinal disorders1/31
FallInjury, poisoning and procedural complications1/31
HyperglycemiaMetabolism and nutrition disorders1/31
Most frequent other events
Showing 10 of 94
Most frequent other events
EventAMG 102
AnemiaBlood and lymphatic system disorders20/31
FatigueGeneral disorders19/31
NauseaGastrointestinal disorders14/31
VomitingGastrointestinal disorders11/31
DyspneaRespiratory, thoracic and mediastinal disorders9/31
ConstipationGastrointestinal disorders8/31
HypomagnesemiaMetabolism and nutrition disorders8/31
AnorexiaMetabolism and nutrition disorders8/31
Peripheral Sensory NeuropathyNervous system disorders8/31
Edema LimbsGeneral disorders7/31

Baseline characteristics

Eligible and treated patients.

Age, Customized
Age, Customized(participants)AMG 102
40-49 years4
50-59 years6
60-69 years9
70-79 years10
80-89 years2
Sex: Female, Male
Sex: Female, Male(Participants)AMG 102
Female31
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AMG 102
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American4
White27
More than one race0
Unknown or Not Reported0
08

Study locations

28 sites
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
  • Florida Hospital Orlando
    Orlando, Florida 32803, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • McFarland Clinic PC-William R Bliss Cancer Center
    Ames, Iowa 50010, United States
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Iowa-Wide Oncology Research Coalition NCORP
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates-Des Moines
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates-Laurel
    Des Moines, Iowa 50314, United States
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Cooper Hospital University Medical Center
    Camden, New Jersey 08103, United States
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina 28203, United States
  • Novant Health Presbyterian Medical Center
    Charlotte, North Carolina 28204, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Summa Akron City Hospital/Cooper Cancer Center
    Akron, Ohio 44304, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
  • Lake University Ireland Cancer Center
    Mentor, Ohio 44060, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Abington Memorial Hospital
    Abington, Pennsylvania 19001, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Women and Infants Hospital
    Providence, Rhode Island 02905, United States
  • Baylor All Saints Medical Center at Fort Worth
    Fort Worth, Texas 76104, United States
  • Carilion Clinic Gynecological Oncology
    Roanoke, Virginia 24016, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01039207
Lead sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 24, 2009
Start date
Oct 2010
Primary completion
Jul 2012
Completion
Jul 2014
Results posted
Sep 7, 2017
Last update
Sep 7, 2017

Study contacts

Lainie Martin
principal investigator · NRG Oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion