Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 107
- 试验地点
- 22
- 主要终点
- Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy.
研究概览
简要总结
Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors.
Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy.
Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).
详细描述
Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%.
Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •colorectal cancer above to 12 cm from the anal verge
- •unresectable synchronous metastases
- •no contraindications for chemotherapy
- •absence of peritoneal carcinomatosis, central nervous system o bone metastasis.
- •performance status ECOG ≤ 2 (Eastern Cooperative Oncology Group)
- •uncontrolled concomitant medical conditions that may compromise to chemotherapy
- •significant symptomatic cardiac disease
- •not pregnancy or breastfeeding
排除标准
- •Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.
- •Multiple bone metastasis or central nervous system metastasis
- •Other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical "in situ" carcinoma
- •Significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months
- •Peripheral neuropathy
- •Patients who do not give informed consent
研究组 & 干预措施
colonic resection
Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
干预措施: Colonic resection (Procedure)
colonic resection
Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
干预措施: Chemotherapy- scheme (Drug)
Chemotherapy
Arm B (control): chemotherapy alone, regimen according to each center
干预措施: Colonic resection (Procedure)
Chemotherapy
Arm B (control): chemotherapy alone, regimen according to each center
干预措施: Chemotherapy- scheme (Drug)
结局指标
主要结局
Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy.
时间窗: up to 2 years
The percentage of patients who are still alive for follow-up at 2 years after randomization.
次要结局
- Postoperative morbidity and mortality.(30 days postoperatively)
- Questionnaire Quality of life CR29(up to 2 years)
- Study of possible survival factors(up to 2 years)
- Complications in patients treated with systemic chemotherapy(up to 2 years)
研究者
Sebastiano Biondo
Phd, MD
Hospital Universitari de Bellvitge