Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

Phase 4

• Conditions: Liver Metastasis; Colorectal Cancer
• Interventions: Procedure: TACE + folfox 4; Procedure: TAC + folfox4

• Registration Number: NCT00868569
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE 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 TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) 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: 2008-01
• 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
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• 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
1	TACE + folfox 4	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 chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.
2	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 operation

Secondary Outcome Measures

Name	Time	Method
resection rate of liver metastasis progression-free survival	5 years after operation

Trial Locations

Locations (1)

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