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

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Fudan University

Status and phase

Unknown
Phase 4

Conditions

Liver Metastasis
Colorectal Cancer

Treatments

Procedure: TACE + folfox 4
Procedure: TAC + folfox4

Study type

Interventional

Funder types

Other

Identifiers

NCT00868569
2009-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated 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 chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.
Treatment:
Procedure: TACE + folfox 4
2
Active Comparator 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

Trial contacts and locations

1

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Central trial contact

jianmin xu, MD, PHD; yunshi zhong, MD

Data sourced from clinicaltrials.gov

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