Vulvar Cancer Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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