Spots Global Cancer Trial Database for Adjuvant Pazopanib in Stage I NSCLC
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Trial Identification
Brief Title: Adjuvant Pazopanib in Stage I NSCLC
Official Title: A Randomized, Double-blind, Placebo-controlled Phase II-III Multi-centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-surgical Disease-free Survival in Patients With Stage I Non Small Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm.
Study ID: NCT00775307
Conditions
Study Description
Brief Summary: The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T \< or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.
Detailed Description: The study will be conducted in two phases as follows: * The Phase II component of the study will be a randomized, double-blind, placebo-controlled, multi-centre study performed in France only. After undergoing NSCLC resection, 140 patients will be randomized to receive either pazopanib 400 mg per day or placebo for 24 weeks. * The Phase III component of the study will be a randomized, double-blind, placebo-controlled, multi-centre study performed internationally. Patients who have completed the Phase II component of the study will be followed and included in the Phase III. Additional patients will also be recruited to a planned total of 355 patients per treatment arm. New patients will be randomized to receive either pazopanib 400 mg per day or placebo for 24 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Annemasse - CH, Ambilly, , France
Bobigny - Hôpital Avicenne, Bobigny, , France
Bordeaux - Polyclinique Nord, Bordeaux, , France
Boulogne - Ambroise Paré, Boulogne, , France
Béziers - CH, Béziers, , France
Caen - Centre François Baclesse, Caen, , France
Caen - CHU Côte de Nacre, Caen, , France
Clamart - Hôpital Percy, Clamart, , France
Clermont Ferrand - CHU, Clermont Ferrand, , France
Colmar - CH, Colmar, , France
Dax - CH, Dax, , France
Grenoble - CHU, Grenoble, , France
Le Mans - Centre Hospitalier, Le Mans, , France
Lille - Hôpital Calmette, Lille, , France
Mantes La Jolie - CH, Mantes La Jolie, , France
Marseille - Hôpital Sainte Marguerite, Marseille, , France
Metz - Clinique Claude Bernard, Metz, , France
Mont de Marsan - CH, Mont de Marsan, , France
Montpellier - Clinique Clémentville, Montpellier, , France
Montpellier - CHRU, Montpellier, , France
Moulins - CH, Moulins, , France
Nantes - Centre René Gauducheau, Nantes, , France
Nevers - CH, Nevers, , France
CHU, Nîmes, , France
Orléans - CH, Orléans, , France
Paris - Saint Louis, Paris, , France
Paris - hôpital Saint-Antoine, Paris, , France
Paris - Hopital Tenon, Paris, , France
Pau - CH, Pau, , France
Centre Catalan d'Onologie, Perpignan, , France
Lyon Sud, Pierre Bénite, , France
Reims - CHU, Reims, , France
Rennes - CHU, Rennes, , France
Strasbourg - NHC, Strasbourg, , France
Thonon les bains - CH, Thonon les bains, , France
Toulon - HIA, Toulon, , France
Toulouse - CHU Larrey, Toulouse, , France
Nancy - CHU, Vandoeuvre lès Nancy, , France
Vesoul - CHI, Vesoul, , France
Villejuif - Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Benjamin BESSE, Dr
Affiliation: Institut Gustave Roussy (IGR)
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Charles SORIA, Pr
Affiliation: Institut Gustave Roussy (IGR)
Role: STUDY_DIRECTOR
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