NCT04416854

The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.

Conditions

• Metastatic Colon Cancer
• Surgery

Interventions

Type	Name	Description
PROCEDURE	resection of primary tumor	resection of primary lesion with unresectablely metastatic colon cancer
DRUG	XELOX	Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
DRUG	mFOLFOX6	Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

1 site across 1 country: China