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Brief Title: Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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 ID: NCT00006479
Brief 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.
Detailed Description: OBJECTIVES: * Compare the progression-free and overall survival of patients with resectable colorectal liver metastases treated with surgery with or without neoadjuvant and adjuvant oxaliplatin, fluorouracil, and leucovorin calcium. * Compare the percentage of patients with total resection with these two treatments. 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. * Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium (LV) IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2. Treatment repeats every 15 days for 6 courses in the absence of disease progression or unacceptable toxicity. 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. * Arm II: Patients undergo liver resection. Patients are followed every 3 months for 2 years and then every 6 months thereafter. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Bankstown - Lidcombe Hospital, Bankstown, New South Wales, Australia
Institute of Oncology at Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Ashford Cancer Centre, Ashford, South Australia, Australia
Flinder Medical Centres, Bedford Park, South Australia, Australia
Queen Elizabeth Hospital, Woodville, South Australia, Australia
Launceston General Hospital, Launceston, Tasmania, Australia
Frankston Hospital, Frankston, Victoria, Australia
Austin and Repatriation Medical Centre, Heidelberg West, Victoria, Australia
Mount Hospital, Perth, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Sir Charles Gairdner Hospital - Perth, Perth, Western Australia, Australia
Allgemeines Krankenhaus der Stadt Wien, Vienna, , Austria
Kaiser Franz Josef Hospital, Vienna, , Austria
Institut Jules Bordet, Brussels, , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels, , Belgium
Universitair Ziekenhuis Gent, Ghent, , Belgium
Hopital de Jolimont, Haine Saint Paul, , Belgium
Cazk Groeninghe - Campus St-Niklaas, Kortrijk, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Centre Hospitalier - Abbeville, Abbeville, , France
Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France
C.H.G. Beauvais, Beauvais, , France
CHR de Besancon - Hopital Jean Minjoz, Besancon, , France
Institut Bergonie, Bordeaux, , France
CHU Ambroise Pare, Boulogne Billancourt, , France
C.H. Bourg En Bresse, Bourg En Bresse, , France
CMC Bligny, Briis Sous Forges, , France
CHU de Caen, Caen, , France
Hopital Louis Pasteur, Colmar, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
Hopital Du Bocage, Dijon, , France
CHU de Grenoble - Hopital de la Tronche, Grenoble, , France
Centre Hospitalier Departemental, La Roche Sur Yon, , France
Clinique Du Pre, Le Mans, , France
Hopital Robert Boulin, Libourne, , France
Centre Hospital Regional Universitaire de Limoges, Limoges, , France
CHU de la Timone, Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Hopital Lariboisiere, Paris, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hopital Cochin, Paris, , France
C.H.G. De Pau, Pau, , France
Hopital Haut Leveque, Pessac, , France
Centre Eugene Marquis, Rennes, , France
Hopital Charles Nicolle, Rouen, , France
Hopital Universitaire Hautepierre, Strasbourg, , France
Centre Hospitalier Regional de Purpan, Toulouse, , France
CHU de Tours, Tours, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Hopital Paul Brousse, Villejuif, , France
Helios Klinikum Berlin, Berlin, , Germany
Robert Roessle Klinik at Charite - Campus Berlin Buch im Helios Klinikum Berlin, Berlin, , Germany
Knappschaft Krankenhaus, Bochum-Langendreer, , Germany
Staedtisches Klinikum Dessau, Dessau, , Germany
Medizinische Klinik I, Dresden, , Germany
Department of Medicine III, Erlangen, , Germany
Kliniken Essen - Mitte, Essen, , Germany
Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Klinik der Justus - Leibig - Universitaet Giessen, Giessen, , Germany
Klinikum der Friedrich-Schiller Universitaet Jena, Jena, , Germany
Universitaet Leipzig, Leipzig, , Germany
Staedtisches Klinikum Leipzig, Leipzig, , Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg, Magdeburg, , Germany
Johannes Gutenberg University, Mainz, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, , Germany
Klinikum der Universitaet Regensburg, Regensburg, , Germany
Caritasklinik St. Theresia, Saarbrucken, , Germany
Eberhard Karls Universitaet, Tuebingen, , Germany
Dr. Horst-Schmidt-Kliniken, Wiesbaden, , Germany
Universitaets-Hautklinik Wuerzburg, Wuerzburg, , Germany
Prince of Wales Hospital, Shatin, N.T., , Hong Kong
Ospedale San Martino/Cliniche Universitarie Convenzionate, Genoa (Genova), , Italy
Universita di Padova, Padova, , Italy
Leiden University Medical Center, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Christchurch Hospital, Christchurch, , New Zealand
Haukeland Hospital - University of Bergen, Bergen, , Norway
Instituto Portugues de Oncologia Centro do Porto, SA, Porto, , Portugal
Sahlgrenska University Hospital, Gothenburg (Goteborg), , Sweden
Karolinska University Hospital/Huddinge, Stockholm, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
North Hampshire Hospital, Basingstoke, England, United Kingdom
Queen Elizabeth Hospital at University of Birmingham, Birmingham, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Bristol Royal Infirmary, Bristol, England, United Kingdom
Addenbrooke's NHS Trust, Cambridge, England, United Kingdom
St. Luke's Cancer Center, Guildford, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust, Leeds, England, United Kingdom
St. James's University Hospital, Leeds, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals, Liverpool, England, United Kingdom
Royal London Hospital, London, England, United Kingdom
Royal Free Hospital, London, England, United Kingdom
St. George's Hospital, London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
Freeman Hospital, Newcastle-Upon-Tyne, England, United Kingdom
Mount Vernon Hospital, Northwood, England, United Kingdom
Queen's Medical Centre, Nottingham, England, United Kingdom
Royal Preston Hospital, Preston, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Royal Infirmary of Edinburgh at Little France, Edinburgh, Scotland, United Kingdom
Ysbyty Gwynedd, Bangor, Wales, United Kingdom
North Manchester Healthcare NHS Trust, Manchester, , United Kingdom
Name: Bernard Nordlinger, MD
Affiliation: Hopital Ambroise Pare
Role:
Name: Euan T. Walpole, MD
Affiliation: Princess Alexandra Hospital
Role: STUDY_CHAIR
Name: Wolf O. Bechstein, MD
Affiliation: Arbeitsgruppe Lebermetastasen und Tumoren
Role: STUDY_CHAIR
Name: John N. Primrose, MD
Affiliation: University Hospital Southampton NHS Foundation Trust
Role: STUDY_CHAIR
Name: Philippe Rougier, MD
Affiliation: Hopital Ambroise Pare
Role: STUDY_CHAIR