NCT02314182已完成3 期
GRECCAR 8 : Impact on Survival of the Primary Tumor Resection in Rectal Cancer With Unresectable Synchronous Metastasis a Randomized Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
A prospective, open, multicenter, randomized III trial with two arms:
- Arm A: Primary tumor resection , followed by chemotherapy
- Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated for resectable rectal adenocarcinoma with unresectable metastasis, treated either with the primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy (+/- target therapy) alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-complicated primary tumor (i.e. tumor without obstruction, bleeding, abscess or perforation requiring emergency surgery and/or contra-indicating first-line chemotherapy)
- •Unresectable synchronous metastases
- •ECOG performance status 0-1
- •Rectal adenocarcinoma (<15 cm from the anal verge) with few or no symptoms and unresectable metastasis (assessed by the investigator) unsuitable for curative treatment
- •No known unresectable primary tumor (with clear margin >1mm) on CT-scan and MRI
- •No disease progression under chemotherapy (for at least 4 cycles);
- •Assessment of KRAS status before randomization (wild type or mutated);
- •Life expectancy without cancer >2 years
- •White blood cell count ≥ 3 x 109/L, with neutrophils ≥ 1,5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin°≥ 9 g/dL (5,6 mmol/l)
- •Total bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN, alkaline phosphatase°≤°1.5°x ULN, serum creatinine ≤ 1.5 x ULN;
- •Age ≥ 18 years ≤ 75 years
- •Patients with childbearing potential should use effective contraception during the study and up 6 months after the end of chemotherapy
- •Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
- •Signed written informed consent obtained prior to any study-specific screening procedures
排除标准
- •Rectal tumor operated before inclusion
- •Symptoms related to the rectal tumor requiring first intention rectal surgery (appreciated by investigator)
- •Contra-indication for surgery
- •Resectable metastases
- •Complicated (obstruction, bleeding, abscess, perforation) primary tumor requiring emergency surgery and/or contra-indicating first line-chemotherapy
- •Non-resectable primary tumor (with wild margin)
- •Age > 75 years < 18 years
- •ECOG performance status > 2
- •Under nutrition (albumin < 30 g/l)
- •Peritoneal carcinomatosis
- •Disease progression under chemotherapy (RECIST 1.1 criteria)
- •Known hypersensitivity reaction or specific contraindications to any of the components of study treatments
- •Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- •Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding;
- •Previous malignancy in the last 5 years
- •Medical, geographical, sociological, psychological or legal conditions that would prevent the patient from completing the study or signing the informed consent; in the investigator's opinion
- •Any significant disease which, in the investigator's opinion, excludes the patient from the study
- •Under an administrative or legal supervision.
研究组 & 干预措施
A Primary tumor resection + chemotherapy
Experimental
PT resection + systemic chemotherapy +/- target therapy
干预措施: Primary tumor resection + chemotherapy (Procedure)
B Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Other
Chemotherapy (+/- target therapy)
干预措施: Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab (Drug)
结局指标
主要结局
Overall survival
时间窗: up to 2 years
Overall survival, defined as the time interval between the date of randomization and the date of death, with a 24 months' follow-up, in both treatment arms.
次要结局
- Progression free survival(up to 2 years)
- Quality of life(Up to 2 years)
- Toxicity of chemotherapy (Common Toxicity Criteria for Adverse Events (NCI-CTC-AE V4.0)(Up to 2 years)
- Response of the metastatic disease to systemic chemotherapy (RECIST 1.1 criteria)(up to2 years)
- Time to disease progression(up to 2 years)
- Post-operative morbidity(within 30 days after surgical intervention)
研究者
研究点 (3)
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