Spots Global Cancer Trial Database for Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
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Trial Identification
Brief Title: Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
Official Title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Study ID: NCT00075452
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma. PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.
Detailed Description: OBJECTIVES: Primary * Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin. Secondary * Compare the time of response in patients treated with these regimens. * Compare the clinical benefit of and tolerance to these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Compare the progression-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity. After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy. Quality of life is assessed at baseline and then every 2 months. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Paul Papin, Angers, , France
C.H.G. Beauvais, Beauvais, , France
Hopital Saint Andre, Bordeaux, , France
CHU Ambroise Pare, Boulogne Billancourt, , France
CMC Bligny, Briis Sous Forges, , France
Hopital Louis Pasteur, Chartres, , France
Chu-Hopital Gabriel Montpied, Clermont Ferrand, , France
Hopital Beaujon, Clichy, , France
Hopital Louis Mourier, Colombes, , France
Hopital Drevon, Dijon, , France
Centre Hospitalier Departemental, La Roche Sur Yon, , France
Hopital Saint - Louis, La Rochelle, , France
Centre Hospitalier de Lagny, Lagny Sur Marne, , France
Hopital Andre Mignot, Le Chesnay, , France
Centre Jean Bernard, Le Mans, , France
C. H. Du Mans, Le Mans, , France
Hopital Robert Boulin, Libourne, , France
Centre Hospital Universitaire Hop Huriez, Lille, , France
Clinique Saint Jean, Lyon, , France
Hopital de la Croix Rousse, Lyon, , France
Hopital Notre-Dame de Bon Secours, Metz, , France
Intercommunal Hospital, Montfermeil, , France
American Hospital of Paris, Neuilly Sur Seine, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hopital Bichat - Claude Bernard, Paris, , France
Hopital de la Croix St. Simon, Paris, , France
Hopital Saint-Louis, Paris, , France
Hopital Saint Antoine, Paris, , France
CHU Pitie-Salpetriere, Paris, , France
Hopital Tenon, Paris, , France
Maison Medicale Marzet, Pau, , France
Hopital Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Clinique Ste - Marie, Pontoise, , France
Polyclinique De Courlancy, Reims, , France
C. H. De Saumur, Saumur, , France
C.H. Senlis, Senlis, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Christophe Louvet, MD, PhD
Affiliation: Hopital Saint Antoine
Role:
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