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Spots Global Cancer Trial Database for Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

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Trial Identification

Brief Title: Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

Official Title: A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes

Study ID: NCT00006096

Conditions

Vulvar Cancer

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Community Hospital of Los Gatos, Los Gatos, California, United States

Chao Family Comprehensive Cancer Center, Orange, California, United States

University of Colorado Cancer Center, Denver, Colorado, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States

Tufts University School of Medicine, Boston, Massachusetts, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

Mallinckrodt Institute of Radiology, Saint Louis, Missouri, United States

Cancer Center of Albany Medical Center, Albany, New York, United States

Schneider Children's Hospital at North Shore, Manhasset, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States

Abington Memorial Hospital, Abington, Pennsylvania, United States

Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Brookview Research, Inc., Nashville, Tennessee, United States

Simmons Cancer Center - Dallas, Dallas, Texas, United States

M.D. Anderson CCOP Research Base, Houston, Texas, United States

Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States

Tacoma General Hospital, Tacoma, Washington, United States

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada

Contact Details

Name: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

Affiliation: GlaxoSmithKline

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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