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

NCT00043004 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2012-09-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

bevacizumab

DRUG

FOLFOX regimen

DRUG

fluorouracil

DRUG

leucovorin calcium

DRUG

oxaliplatin

PROCEDURE

conventional surgery

PROCEDURE

radiofrequency ablation

Sponsors & Collaborators

  • Arbeitsgruppe Lebermetastasen und Tumoren

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Theo Ruers, MD · Universitair Medisch Centrum St. Radboud - Nijmegen

  • Wolf O. Bechstein, MD · Arbeitsgruppe Lebermetastasen und Tumoren

  • Jonathan A. Ledermann, MD · Cancer Research UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2007-06-30

Countries

  • Austria
  • Belgium
  • Egypt
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00043004 on ClinicalTrials.gov