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

NCT ID: NCT00869271

Last Updated: 2009-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-12-31

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.

Conditions

Unresectable Liver Metastasis of Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

tac + folfox4

Intervention Type: PROCEDURE

tac: oxaliplatin 100mg + fudr 1g + mmc 10mg

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.

2

folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle.

Group Type: ACTIVE_COMPARATOR

Folfox4

Intervention Type: PROCEDURE

folfox4

Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle

Interventions

tac + folfox4

tac: oxaliplatin 100mg + fudr 1g + mmc 10mg

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.

Intervention Type: PROCEDURE

Folfox4

folfox4

Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhongshan hospital, Fudan University

Principal Investigators

jianmin xu, MD, PHD

Role: STUDY_DIRECTOR

department of general surgery, zhongshan hospital, fudan university

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2009-01

Identifier Type: -

Identifier Source: org_study_id