Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

DRUG

FOLFOX regimen

DRUG

fluorouracil

DRUG

leucovorin calcium

DRUG

oxaliplatin

PROCEDURE

adjuvant therapy

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

Sponsors & Collaborators

• Australasian Gastro-Intestinal Trials Group

  collaborator NETWORK

• Arbeitsgruppe Lebermetastasen und Tumoren

  collaborator OTHER

• Cancer Research UK

  collaborator OTHER

• Fondation Francaise de Cancerologie Digestive

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Bernard Nordlinger, MD · Hopital Ambroise Pare

• Euan T. Walpole, MD · Princess Alexandra Hospital

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

• John N. Primrose, MD · University Hospital Southampton NHS Foundation Trust

• Philippe Rougier, MD · Hopital Ambroise Pare

Study Design

Purpose

TREATMENT

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-09-30

Countries

• Australia
• Austria
• Belgium
• France
• Germany
• Hong Kong
• Italy
• Netherlands
• New Zealand
• Norway
• Portugal
• Sweden
• United Kingdom

Study Locations