2023-504831-42-00招募中3 期
IRIMAD Interest of postoperative reintroduction of chemotherapy in patients with colorectal liver metastases who responded well to preoperative chemotherapy with FOLFIRI with or without targeted therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 21
- 主要终点
- Disease-free survival rate at 3 years
研究概览
简要总结
Demonstrate an improvement of disease-free survival rate at 3 years
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons. For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer
- •Patients must be 18 years old or older
- •A WHO performance status of 0 or 1
- •Participants must be affiliated to a social security scheme
- •No more than 10 treated CLM at surgery
- •At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy
- •Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery
- •R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
- •Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response
- •No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery. 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases
- •Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
- •No contraindication to FOLFIRI based chemotherapy
排除标准
- •Palliative/R2 resection of CLM
- •10 lesions or more treated at the time of surgery
- •Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy)
- •Extra-hepatic or residual metastasis of CRC
- •Absence of objective response to therapy (radiological or pathological response )
- •Inflammatory bowel disease
- •Known UGT1A1*28 allele homozygosity
- •Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone)
- •Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women
结局指标
主要结局
Disease-free survival rate at 3 years
Disease-free survival rate at 3 years
次要结局
- Overall survival at 3 years
- Liver-free survival at 3 years
- Extra -hepatic recurrence rate
- Safety including chemotherapy associated toxicity assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system
- Compliance defined as the ability to administrate a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment
- Rate of treatment of recurrence with curative intent
研究者
PR Stéphane Benoist
Scientific
Assistance Publique Hopitaux De Paris
研究点 (21)
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