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

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Fudan University

Status and phase

Completed
Phase 4

Conditions

Unresectable Liver Metastasis of Colorectal Cancer

Treatments

Procedure: Folfox4
Procedure: tac + folfox4

Study type

Interventional

Funder types

Other

Identifiers

NCT00869271
2009-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

1
Experimental group
Description:
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.
Treatment:
Procedure: tac + folfox4
2
Active Comparator group
Description:
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle.
Treatment:
Procedure: Folfox4

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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