Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced, Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 160
- 试验地点
- 11
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. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.
详细描述
OBJECTIVES:
- Compare the overall survival and survival without relapse for 1, 3, and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil.
- Compare the presence of distant metastases at 1, 3, and 5 years in these patients after these treatments.
- Compare the local control and duration of control in these patients after these treatments.
- Compare the clinical changes and histological changes at 6 months in these patients after these treatments.
- Determine the rate of complete response in these patients after these treatments.
- Determine the early and late toxic effects of these regimens in these patients.
- Determine the quality of life of these patients.
- Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and primary site of disease (oropharynx vs hypopharynx)
Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7 weeks.
- Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5. Courses are repeated every 3 weeks for 3 courses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven squamous cell cancer of the oropharynx or hypopharynx
- •T4 and nonresectable OR
- •T3 extended to oropharynx or hypopharynx and nonresectable
- •N0-3 (stage III or IV)
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •Neutrophil count at least 2000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN
- •Creatinine no greater than 1.25 times ULN
- •Cardiovascular:
- •No severe cardiac disease
- •No prior malignancy except basal cell skin cancer
- •No uncontrolled infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •No concurrent antineoplastic therapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy
- •No prior surgery (except biopsy or adenectomy)
排除标准
- 未提供