Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Chemotherapy Effect; Hyperthermic Intraperitoneal Chemotherapy; Peritoneal Neoplasms; Peritoneal Cancer; Cytoreductive Surgery; Colorectal Neoplasms; Colorectal Cancer Metastatic; Peritoneal Metastases; Colorectal Cancer

Treatments: Drug: Postoperative chemotherapy; Procedure: CRS+HIPEC; Drug: Preoperative systematic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05353582

STUCS

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Chemotherapy group

Experimental group

Description:

6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.

Treatment:

Drug: Postoperative chemotherapy

Drug: Postoperative chemotherapy

Procedure: CRS+HIPEC

Drug: Preoperative systematic therapy

Upfront surgery group

Active Comparator group

Description:

Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev

Treatment:

Drug: Postoperative chemotherapy

Drug: Postoperative chemotherapy

Procedure: CRS+HIPEC