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

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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)

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

Trial contacts and locations

1

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Central trial contact

jianmin xu, MD, PHD

Data sourced from clinicaltrials.gov

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