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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Australasian Gastro-Intestinal Trials Group Arbeitsgruppe Lebermetastasen und Tumoren Cancer Research UK Fondation Francaise de Cancerologie Digestive |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006479 |
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.
Condition | Intervention | Phase |
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Colorectal Cancer Metastatic Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study |
Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, prior adjuvant chemotherapy (yes vs no), plasma CEA level in ng/mL at diagnosis of liver metastases (5 or less vs 6 to 30 vs 31 or greater), serosa extension of primary cancer (absent T1 or T2 vs present T3 or T4), lymphatic spread of primary cancer (absent vs present N+), time interval between diagnosis of primary tumor to metastases (2 years or more vs fewer than 2 years), and number of metastases (1 to 3 vs 4). Patients are randomized to one of two treatment arms.
At 2 to 5 weeks after chemotherapy, patients undergo liver resection. Patients with progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks after completion of course 3 and do not receive postoperative chemotherapy.
At 2 to 5 weeks after surgery, patients receive oxaliplatin, LV, and 5-FU as in preoperative chemotherapy.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of potentially resectable colorectal liver metastases that meets one of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Investigator: | Bernard Nordlinger, MD | Hopital Ambroise Pare |
Study Chair: | Euan T. Walpole, MD | Princess Alexandra Hospital |
Study Chair: | Wolf O. Bechstein, MD | Arbeitsgruppe Lebermetastasen und Tumoren |
Study Chair: | John N. Primrose, MD | Southampton General Hospital |
Study Chair: | Philippe Rougier, MD | Hopital Ambroise Pare |
Study ID Numbers: | CDR0000068309, EORTC-40983, AGITG-EORTC-40983, ALM-CAO-EORTC-40983, CRUK-LON-EORTC-40983, FFCD-EORTC-40983, EU-20048, CRC-EORTC-40983 |
Study First Received: | November 6, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006479 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Leucovorin Rectal Diseases Oxaliplatin Vitamins Neoplasm Metastasis Micronutrients Digestive System Neoplasms Vitamin B Complex |
Rectal Neoplasm Adjuvants, Immunologic Trace Elements Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Leucovorin Rectal Diseases Neoplastic Processes Oxaliplatin Neoplasms by Site Pathologic Processes Vitamins |
Therapeutic Uses Neoplasm Metastasis Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |