Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 26
- 主要终点
- Complete response rate at 6 months
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill 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. It is not yet known if fluorouracil plus radiation therapy is more effective with or without additional chemotherapy in treating anal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer.
详细描述
OBJECTIVES:
- Compare the response rates in patients with primary epidermoid anal cancer treated with radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without maintenance therapy.
- Compare local control and prevention or delay of disease dissemination in patients treated with these regimens.
OUTLINE: This is randomized, open-label, multicenter study. Patients are randomized to one of four treatment arms.
All patients undergo radiotherapy daily 5 days a week for 5.5 weeks. All patients also receive fluorouracil IV continuously over days 1-4 and 29-32.
- Arm I: Patients receive mitomycin IV on day 1.
- Arm II: Patients receive cisplatin IV on days 1 and 29.
- Arm III: Patients receive mitomycin as in arm I and maintenance therapy comprising fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks after completion of primary therapy and repeating once 3 weeks later.
- Arm IV: Patients receive cisplatin as in arm II and maintenance therapy as in arm III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary epidermoid anal cancer
- •Squamous cell
- •Cloacogenic
- •No adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma, lymphoma, or microinvasive anal intraepithelial neoplasia (without evidence of invasive disease) in the anal canal or margin
- •No metastatic disease
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Liver function tests no greater than 2 times normal
- •Glomerular filtration rate at least 50 mL/min
- •Cardiovascular:
- •No cardiovascular disease
- •No uncontrolled angina pectoris
- •No heart failure
- •No clinically significant cardiac arrhythmias
- •HIV negative
- •No other significant concurrent illness
- •Not predominately bed-bound or frail
- •No severe sepsis
- •No other prior or concurrent cancer or illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to pelvis
- •Not specified
- •No prior therapy for anal cancer
排除标准
- 未提供
结局指标
主要结局
Complete response rate at 6 months
Acute toxicity as measured up to 4 weeks after chemoradiation
Recurrence-free survival
次要结局
- Colostomy rate
- In field recurrence rate as measured by confirmed disease within radiation therapy field
- Cause-specific and overall survival