Spots Global Cancer Trial Database for The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
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Trial Identification
Brief Title: The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
Official Title: Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer
Study ID: NCT00345059
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.
Detailed Description: This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens: * docetaxel * docetaxel + vinorelbine * docetaxel + gemcitabine * docetaxel + capecitabine
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda Ospedaliera Giovanni Paolo II, Sciacca, AG, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica, Monteforte Irpino, AV, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia, Benevento, BN, Italy
Azienda Ospedaliera G. Rummo, Benevento, BN, Italy
Università di Chieti, Chieti, CH, Italy
Ospedali Riuniti, Foggia, FG, Italy
Ospedale Umberto di Frosinone, Frosinone, FR, Italy
Ospedale di Gaeta, Gaeta, LT, Italy
Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano, Cuggiono, MI, Italy
Ospedale Civile di Legnano, Legnano, MI, Italy
Ospedale S. Paolo, Milano, MI, Italy
Ospedale S. Gerado, Monza, MI, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia, Mantova, MN, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico, Palermo, PA, Italy
Azienda Ospedaliera V. Cervello, Palermo, PA, Italy
Ospedale Buccheri La Ferla - Fatebenefratelli, Palermo, PA, Italy
U.L.S.S. 15 Regione Veneto, Cittadella, PD, Italy
Istituto Oncologico Veneto, Padova, PD, Italy
Azienda Ospedaliera Universitaria Senese, Siena, SI, Italy
Ospedale E. Morelli, Sondalo, SO, Italy
Presidio Ospedaliaro Alto Gardo e Ledro, Arco, TN, Italy
Azienda Ospedaliera Di Busto Arsizio, Saronno, VA, Italy
Divisione di Oncologia Medica, U.S.L.L. 13, Noale, VE, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, , Italy
Contact Details
Name: Cesare Gridelli, M.D.
Affiliation: S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D
Affiliation: National Cancer Institute, Naples Italy; Director Clinical Trials Unit
Role: PRINCIPAL_INVESTIGATOR
Name: Ciro Gallo, M.D., Ph.D.
Affiliation: Second University of Naples, Italy; Chair Medical Statistics
Role: PRINCIPAL_INVESTIGATOR
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