A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Accrual rate in months 10 to 12 (phase II)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given alone or together with surgery in treating patients with colorectal cancer.
PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and compares it with surgery followed by chemotherapy in treating patients with metastatic colorectal cancer that can not be removed by surgery.
详细描述
OBJECTIVES:
- To determine whether overall survival is improved in patients with asymptomatic, unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control arm): Patients receive systemic chemotherapy according to standard local practice. Patients who develop symptoms from their primary tumor receive treatment as required including surgery, if indicated.
- Arm II (experimental arm): Patients undergo surgery at the discretion of the surgeon. Beginning 8 weeks after completion of surgery, patients receive chemotherapy according to standard local practice.
Patients complete quality-of-life questionnaires (EQ-5D) at baseline and then periodically during and after completion of study treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed colorectal cancer
- •Metastases which are unresectable at presentation
- •No known unresectable primary tumor on CT/MRI scan
- •Primary tumor does not require immediate or emergency intervention including surgery, radiotherapy, laser, or stenting
- •Patients who are treated with colonic stents are eligible
- •No unequivocal extensive peritoneal metastases
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Must be fit for systemic chemotherapy and surgery
- •Hemoglobin > 10.0 g/dL
- •WBC > 3.0 x 10^9/L
- •Platelet count > 100 x 10^9/L
- •Bilirubin < 25 μmol/L
- •GFR > 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months (female) or up to 2 months (male) after completion of study therapy
- •No history of malignant disease within the past 5 years except for nonmelanomatous skin cancer or carcinoma in situ of the cervix
- •No serious medical co-morbidity (e.g., uncontrolled inflammatory bowel disease, uncontrolled angina, recent [within the past 6 months] myocardial infarction, or another serious medical condition) judged to compromise ability to tolerate chemotherapy and/or surgery
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Concurrent participation in a trial of chemotherapy, if eligible, allowed
- •Concurrent short-course radiotherapy for operable rectal cancer allowed
排除标准
- 未提供
结局指标
主要结局
Accrual rate in months 10 to 12 (phase II)
Overall survival for ≥ 2 years (phase III)
次要结局
- Morbidity of surgery (phase II)
- Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
- Morbidity of chemotherapy and surgery (phase III)
- Quality of life (phase III)
- Economic evaluation (phase III)