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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006096 |
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.
Condition | Intervention | Phase |
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Vulvar Cancer |
Drug: cisplatin Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes |
Study Start Date: | March 2001 |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
Study Chair: | Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon) | GlaxoSmithKline |
Study ID Numbers: | CDR0000068103, GOG-0185 |
Study First Received: | August 3, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006096 History of Changes |
Health Authority: | United States: Federal Government |
stage I vulvar cancer stage II vulvar cancer stage III vulvar cancer stage IV vulvar cancer squamous cell carcinoma of the vulva |
Vulvar Cancer Genital Neoplasms, Female Adjuvants, Immunologic Urogenital Neoplasms Squamous Cell Carcinoma Carcinoma Genital Diseases, Female |
Cisplatin Radiation-Sensitizing Agents Vulvar Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell Vulvar Diseases |
Antineoplastic Agents Physiological Effects of Drugs Genital Neoplasms, Female Urogenital Neoplasms Pharmacologic Actions Genital Diseases, Female Neoplasms |
Neoplasms by Site Cisplatin Radiation-Sensitizing Agents Vulvar Neoplasms Therapeutic Uses Vulvar Diseases |