NCT05353582

Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Colorectal Cancer
• Colorectal Cancer Metastatic
• Peritoneal Metastases
• Peritoneal Cancer
• Peritoneal Neoplasms
• Chemotherapy Effect
• Cytoreductive Surgery
• Hyperthermic Intraperitoneal Chemotherapy

Interventions

Type	Name	Description
DRUG	Preoperative systematic therapy	6 cycles of mFOLFOXIRI±Bev is administrated before CRS+HIPEC. Irinotecan165mg/m2 IV day 1, oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted. Bev will not be administrated in at the last two cycles for minimizing surgery complications.
PROCEDURE	CRS+HIPEC	CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.
DRUG	Postoperative chemotherapy	6 cycles of mFOLFOX+Bev is administrated after CRS+HIPEC. Oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2 IV bolus day 1,5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted.
DRUG	Postoperative chemotherapy	12 cycles of mFOLFOX+Bev is administrated after CRS+HIPEC. Oxaliplatin 85mg/m2 IV day 1, leucovorin 400mg/m2 IV day , bevacizumab mg/kg IV day 1, 5-fluorouracil 400mg/m2 IV bolus day 1,5-fluorouracil 400mg/m2, continuous infusion over 46-48h. Dose reduction is permitted.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: China