A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 140
- 主要终点
- Assessment of resection rate (R0/R1)
研究概览
简要总结
Primary Objective:
-Evaluate the resection rate (R0/R1) in current practice for aflibercept in combination with irinotecan plus 5-fluorouracil (FOLFIRI) in patients treated for metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-containing regimen
Secondary Objectives:
- Evaluate overall survival, progression-free survival and relapse-free survival.
- Evaluate conversion rates (initially unresectable disease which became resectable after chemotherapy, with R0/R1 resection).
- Evaluate histological and radiological response rates.
- Evaluate rate of postoperative complications.
- Evaluate safety.
详细描述
The estimated inclusion period is 45 months. Patient follow-up is 24 months and the total study duration is 69 months. Last patient status (alive or dead) collected before database lock.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients treated with aflibercept in combination with FOLFIRI for mCRC after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-EGFR and patients treated with oxaliplatin in the adjuvant setting).
- •Exclusively or predominantly hepatic metastases (≤ 5 pulmonary nodules < 2 cm).
- •Age > 18 years.
- •Signed consent for collection of personal and medical data.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
排除标准
- •Concomitant participation in a clinical trial.
- •Patient receiving concomitant anti-VEGF agents and/or receiving aflibercept as part of a clinical trial or in a compassionate use program.
- •Patient receiving aflibercept in combination with chemotherapy other than FOLFIRI.
- •Patient with contra-indication to surgery.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Cohort 1
Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen
干预措施: Fluorouracil (Drug)
Cohort 1
Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen
干预措施: Aflibercept (Drug)
Cohort 1
Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen
干预措施: Irinotecan (Drug)
结局指标
主要结局
Assessment of resection rate (R0/R1)
时间窗: Up to 24 months
R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status)
次要结局
- Progression-free surivival(Up to 69 months)
- Histological response of resected patients via modified Blazer assessment(Up to 69 months)
- Rate of 90-day postoperative complications using DINDO-CLAVIEN classification(Up to 69 months)
- Overall survival(Up to 69 months)
- Objective Response(Up to 69 months)
- Histological response of resected patients via Tumor Regression Grade (TRG)(Up to 69 months)
- Conversion rate(Up to 69 months)
- Histological response of resected patients via Modified Tumor Regression Grade (mTRG)(Up to 69 months)
- Relapse-free surivial(Up to 69 months)
- Histological response of resected patients via Sebagh assessment(Up to 69 months)
- Histoligical response of resected patients via Blazer assessment(Up to 69 months)
- Radiological response for all patients using RECIST 1.1 criteria(Up to 69 months)
- Safety (serious and non-serious adverse events occurring during treatment(Up to 69 months)