Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer

Phase 4

Completed

• Conditions: Unresectable Liver Metastasis of Colorectal Cancer
• Interventions: Procedure: Folfox4; Procedure: tac + folfox4

• Registration Number: NCT00869271
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Detailed Description

We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Last Update Submitted: 2009-03-24
• Study First Posted: 2009-03-25
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age < 75 years with histologically proven adenocarcinoma of the colon or rectum
• no severe major organ dysfunction
• WHO performance status of 0 or 1
• no prior cancer therapy
• with measurable unresectableliver metastasis
• without other metastasis

Exclusion Criteria

• age >= 75
• severe major organ dysfunction
• WHO performance status of >1
• prior cancer therapy
• with other metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Folfox4	folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle.
1	tac + folfox4	folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.

Primary Outcome Measures

Name	Time	Method
overall survival	5 years after diagnosis

Secondary Outcome Measures

Name	Time	Method
progression free survival	5 years after diagonsis

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China