Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: tac + folfox4; Drug: folfox4

Study type: Interventional

Funder types: Other

Identifiers

NCT00874406

2009-04

Details and patient eligibility

About

The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

Full description

We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age <= 75 years
• resectable liver metastasis
• remnant liver volume >= 70%
• without other organ metastasis or peritoneum metastasis
• without contradiction of cardiac and pulmonary diseases

Exclusion criteria

• age > 75 years
• unresectable liver metastasis
• remnant liver volume < 50%
• with other organ metastasis or peritoneum metastasis
• with contradiction of cardiac and pulmonary diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Experimental group

Description:

transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.

Treatment:

Drug: tac + folfox4

2

Active Comparator group

Description:

Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.

Treatment:

Drug: folfox4