Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

NCT05353582 | Unknown Phase 2

• 1 other identifier: STUCS
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  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.

  Up to five years after randomization

Secondary Outcomes (6)

• 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

Study Arms (2)

Chemotherapy group

EXPERIMENTAL

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

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

Upfront surgery group

ACTIVE COMPARATOR

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

Procedure: CRS+HIPEC; Drug: Postoperative chemotherapy

Interventions

Preoperative systematic therapy DRUG

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.

Chemotherapy group

CRS+HIPEC PROCEDURE

CRS+HIPEC aims to achieve CC0/CC1 resection. Oxaliplatin or mitomycin C is determined by the treating physician.

Chemotherapy group; Upfront surgery group

Postoperative chemotherapy DRUG

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.

Chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Central Study Contacts

Hui Wang, MD

CONTACT

+86-13926424886; wang89@mail.sysu.edu.cn

Huaiming Wang

CONTACT

wanghm@mail.ssysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)