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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Collaborators: |
Australasian Gastro-Intestinal Trials Group Arbeitsgruppe Lebermetastasen und Tumoren Cancer Research UK Fondation Francaise de Cancerologie Digestive |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006479 |
Purpose
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 |
|---|---|---|
|
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: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations
Show 111 Study Locations| 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 University Hospitals NHS Trust |
| Study Chair: | Philippe Rougier, MD | Hopital Ambroise Pare |
More Information
| ClinicalTrials.gov Identifier: | NCT00006479 History of Changes |
| Other 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: | April 15, 2011 |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
|
Colorectal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Liver Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes |
Pathologic Processes Liver Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |