- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006096
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva.
PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the recurrence-free interval and survival in patients with stage I, II, III, or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks.
- Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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California
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Los Gatos, California, United States, 95032
- Community Hospital of Los Gatos
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Colorado
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University School of Medicine
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63108
- Mallinckrodt Institute of Radiology
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New York
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Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
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Manhasset, New York, United States, 11030
- Schneider Children's Hospital at North Shore
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati, Ohio, United States, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, United States, 17033-0850
- Milton S. Hershey Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Brookview Research, Inc.
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, United States, 77030-4009
- M.D. Anderson CCOP Research Base
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Vermont
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - Medical Center Campus
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Washington
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Tacoma, Washington, United States, 98405
- Tacoma General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed stage I, II, III, or IVA squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both
- At least 1 positive inguinal and/or femoral lymph node
- No inoperable (fixed or ulcerating) groin nodes
- Must not require resection of urethra or anal sphincter to achieve negative margins
- Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Granulocyte count at least 1,500/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- Alkaline phosphatase no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy
Surgery:
- See Disease Characteristics
- No more than 8 weeks since prior surgery
Other:
- No prior therapy for another malignancy that would preclude study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon), GlaxoSmithKline
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068103
- GOG-0185
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vulvar Cancer
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer | Vulvar Squamous Cell Carcinoma | Stage I Vulvar Cancer | Stage II Vulvar CancerUnited States, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedLymphedema | Perioperative/Postoperative Complications | Stage II Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Stage IA Vulvar Cancer AJCC v7 | Stage IB Vulvar Cancer AJCC v7 | Stage IVB...United States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage II Vulvar Cancer AJCC v8 | Stage IIIC Vulvar Cancer AJCC v8 | Stage IVA Vulvar Cancer AJCC v8 | Stage III Vulvar Cancer AJCC v8 | Stage IIIA Vulvar Cancer AJCC v8 | Stage IIIB Vulvar Cancer AJCC v8United States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Vulvar Squamous Cell Carcinoma | Stage IVA Vulvar Cancer AJCC v7United States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)UnknownLymphedema | Stage II Uterine Corpus Cancer | Stage IVB Vulvar Cancer | Stage IA Uterine Corpus Cancer | Stage IB Uterine Corpus Cancer | Stage IA Cervical Cancer | Stage IB Cervical Cancer | Stage II Vulvar Cancer | Stage IIA Cervical Cancer | Stage IA Vulvar Cancer | Stage IB Vulvar Cancer | Stage IIIA Vulvar... and other conditionsUnited States
-
Far Eastern Memorial HospitalGynecologic Oncology GroupRecruitingVulvar Cancer, G9a ProteinTaiwan
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AGO Research GmbHNot yet recruitingRecurrent Vulvar Cancer | Persistent Vulvar Cancer | Metastatic Vulva Cancer | Locally Advanced Vulvar Cancer
-
University of BaselUniversity Hospital Inselspital, Berne; Foundation Cancer Research SwitzerlandUnknownWomen With Vulvar Intraephitelial Neoplasia or Vulvar CancerSwitzerland, Germany
-
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