|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| 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: | 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
Hide Study Locations| Australia, New South Wales | |
| Bankstown - Lidcombe Hospital | |
| Bankstown, New South Wales, Australia, NSW 2200 | |
| Institute of Oncology at Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Newcastle Mater Misericordiae Hospital | |
| Waratah, New South Wales, Australia, 2298 | |
| Royal North Shore Hospital | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Australia, Queensland | |
| Princess Alexandra Hospital | |
| Brisbane, Queensland, Australia, 4102 | |
| Royal Brisbane and Women's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Ashford Cancer Centre | |
| Ashford, South Australia, Australia, 5035 | |
| Flinder Medical Centres | |
| Bedford Park, South Australia, Australia, 5042 | |
| Queen Elizabeth Hospital | |
| Woodville, South Australia, Australia, 5011 | |
| Australia, Tasmania | |
| Launceston General Hospital | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Austin and Repatriation Medical Centre | |
| Heidelberg West, Victoria, Australia, 3081 | |
| Frankston Hospital | |
| Frankston, Victoria, Australia, 3199 | |
| Australia, Western Australia | |
| Mount Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Sir Charles Gairdner Hospital - Perth | |
| Perth, Western Australia, Australia, 6009 | |
| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| Kaiser Franz Josef Hospital | |
| Vienna, Austria, A-1100 | |
| Belgium | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Cazk Groeninghe - Campus St-Niklaas | |
| Kortrijk, Belgium, B-8500 | |
| France | |
| C.H. Bourg En Bresse | |
| Bourg En Bresse, France, 01012 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| C.H.G. De Pau | |
| Pau, France, 64000 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Centre Hospitalier - Abbeville | |
| Abbeville, France, 80101 | |
| Centre Hospitalier Departemental | |
| La Roche Sur Yon, France, F-85025 | |
| Centre Hospitalier Regional de Purpan | |
| Toulouse, France, 31059 | |
| Centre Hospitalier Regional et Universitaire d'Angers | |
| Angers, France, 49033 | |
| Centre Hospitalier Universitaire Henri Mondor | |
| Creteil, France, 94010 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| CHR de Besancon - Hopital Jean Minjoz | |
| Besancon, France, 25030 | |
| CHU Ambroise Pare | |
| Boulogne Billancourt, France, F-92104 | |
| CHU de Caen | |
| Caen, France, 14033 | |
| CHU de Grenoble - Hopital de la Tronche | |
| Grenoble, France, 38043 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| CHU de Tours | |
| Tours, France, 37044 | |
| Clinique Du Pre | |
| Le Mans, France, F-72018 | |
| CMC Bligny | |
| Briis Sous Forges, France, 91640 | |
| Hopital Charles Nicolle | |
| Rouen, France, 76031 | |
| Hopital Cochin | |
| Paris, France, 75674 | |
| Hopital Du Bocage | |
| Dijon, France, 21034 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| Hopital Lariboisiere | |
| Paris, France, 75010 | |
| Hopital Louis Pasteur | |
| Colmar, France, 68024 | |
| Hopital Paul Brousse | |
| Villejuif, France, 94804 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Hopital Universitaire Hautepierre | |
| Strasbourg, France, 67098 | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Germany | |
| Caritasklinik St. Theresia | |
| Saarbrucken, Germany, D-66113 | |
| Department of Medicine III | |
| Erlangen, Germany, D-91054 | |
| Dr. Horst-Schmidt-Kliniken | |
| Wiesbaden, Germany, D-65199 | |
| Eberhard Karls Universitaet | |
| Tuebingen, Germany, D-72076 | |
| Helios Klinikum Berlin | |
| Berlin, Germany, 13125 | |
| Johannes Gutenberg University | |
| Mainz, Germany, D-55101 | |
| Klinik der Justus - Leibig - Universitaet Giessen | |
| Giessen, Germany, D-35385 | |
| Medizinische Klinik I | |
| Dresden, Germany, D-01307 | |
| Klinikum der Friedrich-Schiller Universitaet Jena | |
| Jena, Germany, D-07740 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Klinikum der Universitaet Regensburg | |
| Regensburg, Germany, D-93053 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Knappschaft Krankenhaus | |
| Bochum-Langendreer, Germany, D-44892 | |
| Kliniken Essen - Mitte | |
| Essen, Germany, D-45136 | |
| Robert Roessle Klinik at Charite - Campus Berlin Buch im Helios Klinikum Berlin | |
| Berlin, Germany, D-13122 | |
| Staedtisches Klinikum Dessau | |
| Dessau, Germany, D-06822 | |
| Staedtisches Klinikum Leipzig | |
| Leipzig, Germany, D-04129 | |
| Universitaet Leipzig | |
| Leipzig, Germany, D-04103 | |
| Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | |
| Magdeburg, Germany, D-39120 | |
| Universitaetsklinikum Freiburg | |
| Freiburg, Germany, D-79106 | |
| Universitaets-Hautklinik Wuerzburg | |
| Wuerzburg, Germany, D-97080 | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Shatin, N.T., Hong Kong | |
| Italy | |
| Ospedale San Martino/Cliniche Universitarie Convenzionate | |
| Genoa (Genova), Italy, 16132 | |
| Universita di Padova | |
| Padova, Italy, 35128 | |
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| New Zealand | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 1 | |
| Norway | |
| Haukeland Hospital - University of Bergen | |
| Bergen, Norway, N-5021 | |
| Portugal | |
| Instituto Portugues de Oncologia Centro do Porto, SA | |
| Porto, Portugal, 4200-072 | |
| Sweden | |
| Karolinska University Hospital/Huddinge | |
| Stockholm, Sweden, S-171 76 | |
| Sahlgrenska University Hospital | |
| Gothenburg (Goteborg), Sweden, S-413 45 | |
| Uppsala University Hospital | |
| Uppsala, Sweden, S-75185 | |
| United Kingdom | |
| North Manchester Healthcare NHS Trust | |
| Manchester, United Kingdom, M8 6RB | |
| United Kingdom, England | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| North Hampshire Hospital | |
| Basingstoke, England, United Kingdom, RG24 9NA | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Cookridge Hospital at Leeds Teaching Hospital NHS Trust | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Freeman Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Bristol Royal Infirmary | |
| Bristol, England, United Kingdom, BS2 8HW | |
| Queen Elizabeth Hospital at University of Birmingham | |
| Birmingham, England, United Kingdom, B15 2TH | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Royal Free Hospital | |
| London, England, United Kingdom, NW3 2QG | |
| Royal Liverpool and Broadgreen Hospitals | |
| Liverpool, England, United Kingdom, L7 8XP | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Royal Preston Hospital | |
| Preston, England, United Kingdom, PR2 9HT | |
| Royal London Hospital | |
| London, England, United Kingdom, E1 1BB | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
| St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| St. Luke's Cancer Center | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Scotland | |
| Royal Infirmary of Edinburgh at Little France | |
| Edinburgh, Scotland, United Kingdom, EH3 9YW | |
| United Kingdom, Wales | |
| Ysbyty Gwynedd | |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| 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 |
More Information
| 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: | July 10, 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 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 |