Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,997
- 试验地点
- 117
- 主要终点
- Overall survival rate
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.
PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.
详细描述
OBJECTIVES:
- Evaluate the efficacy of reinforced versus standard follow-up care and the utility of follow-up CEA assessments in patients with fully resected stage II or III colorectal cancer.
OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.
- Standard follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo abdominal ultrasound every 3 months until year 3 and then every 6 months until year 5; chest x-ray every 6 months until year 3 and then annually until year 5; and colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
- Reinforced follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo alternate assessments every 3 months comprising thoraco-abdomino-pelvic CT scan or abdominal ultrasound until year 3 and then every 6 months until year 5. They also undergo colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Pathologically confirmed adenocarcinoma of the colon or rectum
- •Stage II or III disease
- •No distant metastatic disease
- •Has undergone curative resection for no residual tumor
- •Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No inflammatory bowel disease
- •No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix
- •No genetic syndromes
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Standard Monitoring CEA/ Standard Imagery
No specific follow-up of CEA and Standard imagery
干预措施: Standard Monitoring CEA (Procedure)
Intensive monitoring CEA/ Standard Imagery
Intensive follow-up CEA and Standard imagery .
干预措施: Standard Monitoring Imagery (Procedure)
Standard Monitoring CEA/ Standard Imagery
No specific follow-up of CEA and Standard imagery
干预措施: Standard Monitoring Imagery (Procedure)
Intensive monitoring CEA/ Standard Imagery
Intensive follow-up CEA and Standard imagery .
干预措施: Intensive Monitoring CEA (Procedure)
Intensive Monitoring CEA / Intensive Monitoring Imagery
Intensive follow-up CEA and Intensive imagery
干预措施: Intensive Monitoring CEA (Procedure)
Intensive Monitoring CEA / Intensive Monitoring Imagery
Intensive follow-up CEA and Intensive imagery
干预措施: Intensive Monitoring Imagery (Procedure)
Standard Monitoring CEA/ Intensive Monitoring Imagery
No specific follow-up of CEA and Intensive Imagery
干预措施: Standard Monitoring CEA (Procedure)
Standard Monitoring CEA/ Intensive Monitoring Imagery
No specific follow-up of CEA and Intensive Imagery
干预措施: Intensive Monitoring Imagery (Procedure)
结局指标
主要结局
Overall survival rate
时间窗: 5 years
Time between randomization and date of death (all causes)
次要结局
- Disease-free survival rate(5 years)