Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Phase 2

Not yet recruiting

• Conditions: Colorectal Neoplasms; Peritoneal Neoplasms; Cytoreductive Surgery; Peritoneal Cancer; Hyperthermic Intraperitoneal Chemotherapy; Colorectal Cancer; Peritoneal Metastases; Chemotherapy Effect; Colorectal Cancer Metastatic
• Interventions: Drug: Preoperative systematic therapy; Procedure: CRS+HIPEC; Drug: Postoperative chemotherapy

• Registration Number: NCT05353582
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29
• Study Start: 2022-06-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy group	CRS+HIPEC	6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
Upfront surgery group	Postoperative chemotherapy	Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
Chemotherapy group	Postoperative chemotherapy	6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
Upfront surgery group	CRS+HIPEC	Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
Chemotherapy group	Preoperative systematic therapy	6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.

Primary Outcome Measures

Name	Time	Method
Progression free survival	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.

Secondary Outcome Measures

Name	Time	Method
Response to preoperative systematic therapy	About 4 months after randomization	Assessed by tumor regression grade
Major adverse events of systematic therapy	Up to 8 months after randomization	Grade ≥3 adverse events by CTCAE 5.0
Overall survival	Up to five years after randomization	From randomization to death of any cause
Intraoperative peritoneal cancer index	About 4 months after randomization	Peritoneal cancer index (PCI) is a tool which sum scores in thirteen abdominal regions according to tumor size.
Complete cytoreductive surgery	About 4 months after randomization	R0/R1 resection or CC0/CC1 resection
Hospitalization time	About 4 months after randomization	Safety of cytoreductive surgery

Trial Locations

Locations (1)

Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China