Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Overall survival
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 whether surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer.
PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery.
详细描述
OBJECTIVES:
- Compare the complete response rate, disease-free survival, and overall survival of patients with resectable (nonmetastatic) stage III or IV squamous cell cancer of the head and neck treated with surgery and adjuvant radiotherapy versus concurrent chemo-radiotherapy.
OUTLINE: This is a randomized study. Patients are stratified according to primary site of disease (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node negative vs positive).
- Arm I: Patients undergo resection of the tumor, followed no more than 6 weeks later by radiotherapy to the primary tumor and upper neck once a day, 5 days a week, for 6 weeks.
- Arm II: Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and cisplatin. Radiotherapy is given once a day, 5 days a week, for 6.5 weeks to the primary tumor and upper neck. Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy. A second course of fluorouracil and cisplatin is given on day 28.
Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed head and neck squamous cell cancer (excluding nasopharynx and salivary glands) on biopsy of the primary lesion or the neck mass
- •Stage III or IV disease
- •No evidence of distant or systemic metastases
- •Resectable disease
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3000/mm^3
- •Platelet count greater than 100,000/mm^3
- •SGOT less than 2 times upper limit of normal
- •Bilirubin less than 1.4 mg/dL
- •Creatinine less than 1.6 mg/dL
- •No prior or concurrent primary malignancies
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to the head and neck
- •See Disease Characteristics
- •No prior surgery (other than biopsy)
排除标准
- 未提供
结局指标
主要结局
Overall survival
Response at 6 weeks after completion of study treatment
Disease-free survival
次要结局
未报告次要终点