A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 试验地点
- 60
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status:
- •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
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 3 times normal
- •Alkaline phosphatase no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •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
- •See Disease Characteristics
- •No more than 8 weeks since prior surgery
- •No prior therapy for another malignancy that would preclude study
排除标准
- 未提供