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

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)

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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