Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin;
- •Tolerable to scheduled chemotherapy;
- •No evidence of extraperitoneal metastases at enrollment;
- •Resectable disease determined by radiological and laparoscopy/laparotomy;
- •No systematic therapy within 6 months before enrollment;
- •Tolerable to cytoreductive surgery.
排除标准
- •Without adequate organ function (e.g. :neutrophil countt≤1.5×10^9/L, or platelets≤75×10^12/L，or hemoglobin<90g/L, or aminotransferase、aspartate aminotransferaseAST<2.5ULN, or total bilirubin<1.5ULN, or creatinine<1.5ULN;
- •Emergency surgery;
- •Recent thromboembolic event or cerebrovascular disease (12 months before enrollment);
- •Pregnancy or lactation
- •Comorbid with severe physical or mental disease.
研究组 & 干预措施
Chemotherapy group
6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
干预措施: Preoperative systematic therapy (Drug)
Chemotherapy group
6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
干预措施: CRS+HIPEC (Procedure)
Chemotherapy group
6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
干预措施: Postoperative chemotherapy (Drug)
Upfront surgery group
Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
干预措施: CRS+HIPEC (Procedure)
Upfront surgery group
Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
干预措施: Postoperative chemotherapy (Drug)
结局指标
主要结局
Progression free survival
时间窗: Up to five years after randomization
From randomization to progression by RECIST1.1, or appearance of measurable lesion after non-measureable lesion, or intraoperative unresectable disease, or recurrence after surgery, or death from any reason.
次要结局
- Response to preoperative systematic therapy(About 4 months after randomization)
- Major adverse events of systematic therapy(Up to 8 months after randomization)
- Overall survival(Up to five years after randomization)
- Intraoperative peritoneal cancer index(About 4 months after randomization)
- Complete cytoreductive surgery(About 4 months after randomization)
- Hospitalization time(About 4 months after randomization)
研究者
Yanhong Deng
Director
Sun Yat-sen University