Spots Global Cancer Trial Database for TAilored Post-Surgical Therapy in Early Stage NSCLC
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Trial Identification
Brief Title: TAilored Post-Surgical Therapy in Early Stage NSCLC
Official Title: Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).
Study ID: NCT00775385
Conditions
Study Description
Brief Summary: Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib. The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier, Aix en Provence, , France
Clinique de L'Europe, Amiens, , France
Angers - CHU, Angers, , France
Centre Hospitalier, Béziers, , France
Centre F. Baclesse, Caen, , France
CHU - Pneumologie, Caen, , France
Centre Hospitalier, Chauny, , France
Chevilly Larue - CH, Chevilly Larue, , France
Hôpital Percy-Armées - Pneumologie, Clamart, , France
Clermont Ferrand - CHU, Clermont Ferrand, , France
Colmar - CH, Colmar, , France
Dax - CH, Dax, , France
Ermont - Clinique Claude Bernard, Ermont, , France
CHU Grenoble - pneumologie, Grenoble, , France
Le Mans - CHG, Le Mans, , France
Centre Léon Bérard, Lyon, , France
Lyon - Hôpital Louis Pradel (Pneumologie), Lyon, , France
Mantes La Jolie - CH, Mantes La Jolie, , France
APHM - Hôpital Sainte Marguerite, Marseille, , France
Institut Paoli Calmette, Marseille, , France
Metz - Belle Isle, Metz, , France
Mont de Marsan - CH, Mont de Marsan, , France
Montpellier - Clinique Clémentville, Montpellier, , France
Mulhouse - CH, Mulhouse, , France
Nancy - Polyclinique Gentilly, Nancy, , France
Nevers - CH, Nevers, , France
Paris - Saint Louis, Paris, , France
APHP - Hopital Tenon - Pneumologie, Paris, , France
Pau - CH, Pau, , France
HCL - Lyon Sud (Pneumologie), Pierre Bénite, , France
Reims - CHU, Reims, , France
Rennes - CHU, Rennes, , France
Centre Hospitalier, Saint-Quentin, , France
Nouvel Hopital Civil, Strasbourg, , France
Hôpital Foch, Suresnes, , France
Centre Hospitalier Intercommunal, Toulon, , France
CHU Toulouse - Pneumologie, Toulouse, , France
Clinique Pasteur, Toulouse, , France
Tours - CHU, Tours, , France
Nancy - CHU, Vandoeuvre lès Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Centre Hospitalier Intercommunal, Villeneuve-Saint-Georges, , France
Contact Details
Name: Jean-Charles SORIA, Pr
Affiliation: Institut Gustave Roussy (IGR)
Role: PRINCIPAL_INVESTIGATOR
Name: Marie Wislez, Pr
Affiliation: APHP - Hôpital Tenon (Paris)
Role: PRINCIPAL_INVESTIGATOR
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