A Phase 3 interventional study of cisplatin and radiation therapy in Vulvar Cancer, sponsored by Gynecologic Oncology Group. Terminated at 30 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2013-06-10.
Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
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.
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.
210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.
Browse Vulvar Neoplasms studies →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.
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is terminated, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group