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Spots Global Cancer Trial Database for Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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