Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT00043004
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • FOLFOX regimen — DRUG
  • fluorouracil — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG
  • conventional surgery — PROCEDURE
  • radiofrequency ablation — PROCEDURE

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases. PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.

Key Dates

First listed
Jan 27, 2003
Start date
May 31, 2002
Status verified
Sep 2012
Primary completion
Jun 30, 2007

Study Design

Enrollment
119 participants (actual)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Survival rate as measured by Kaplan Meier method at 30 months

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