Spots Global Cancer Trial Database for Maintenance Low Dose Oral Navelbine In Patients With Non Small Cell Lung Cancer - MA.NI.LA Trial
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Trial Identification
Brief Title: Maintenance Low Dose Oral Navelbine In Patients With Non Small Cell Lung Cancer - MA.NI.LA Trial
Official Title: Maintenance Metronomic Per OS Navelbine In Advanced NSCLC Patients After Previous Platinum Based Chemotherapy: A Multicenter Randomized Best Supportive Care Controlled Phase II Study - MA.NI.LA. Trial
Study ID: NCT02176369
Interventions
Study Description
Brief Summary: Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death worldwide with 1.4 millions of deaths every years. Current standard therapies include platinum-containing drugs but at one year from diagnosis the survival rate is still low (30-40%) . The purpose of this study is to evaluate the role of a platinum-free drug, named Vinorelbine, administered by the so called "metronomic schedule" in order to prolong the progression free survival of patients.
Detailed Description: Systemic therapy remains the mainstay of treatment of advanced stage NSCLC. Combination chemotherapy with a platinum-based regimen has emerged as standard therapy for patients with advanced stage disease. Observations supported by the findings of several clinical trial, established the notion that an efficacy plateau had been reached in advanced stage NSCLC patients treated with platinum-containing drugs. Recent phase III trials suggest the benefit of "switch" and "continuing" maintenance treatment with different drugs. As "switched therapy", Vinorelbine has been selected on the base of its anti-mitotic role. In fact, the use of anti-mitotic drugs at lower dose but with higher frequency (metronomic schedule) seems to augment the anti-angiogenetic effect of this kind of drugs, thus augmenting the efficacy of the therapy. Therefore, the purpose of the current study is to evaluate the role of a "switched maintenance" with oral vinorelbine administered as a metronomic schedule in terms of Progression Free Survival (PFS) in advanced NSCLC patients with stable disease after first line platinum based chemotherapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ospedale di Gesù Fatebenefratelli, Benevento, BN, Italy
ASL Brindisi - Stabilimento Ospedaliero Di Summa-Perrino, Brindisi, BR, Italy
ASP di Bolzano - Comprensorio sanitario di Bolzano, Bolzano, BZ, Italy
Ospedale Civile SS. Annunziata, Chieti, CH, Italy
A. Ospedaliero-Universitaria Policlinico Vittorio Enmanuele, Catania, CT, Italy
A.O. Villa Scassi, Genova, GE, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, MI, Italy
A.O. Ospedale di Circolo di Melegnano - P.O. Vizzolo Predabissi, Vizzolo Predabissi, MI, Italy
A.O. V. Cervello, Palermo, PA, Italy
Casa di Cura La Maddalena, Palermo, PA, Italy
AUSL Piacenza - Ospedale Guglielmo da Saliceto, Piacenza, PC, Italy
A.O. Santa Maria Degli Angeli, Pordenone, PN, Italy
Azienda USL 4 Prato - O.C. Misericordia e Dolce, Prato, PO, Italy
Azienda Ulss18 - Ospedale S.M. della Misericordia, Rovigo, RO, Italy
Ospedale Morelli, Sondalo, SO, Italy
A.O. Valtellina e Valchiavenna - Ospedale di Sondrio, Sondrio, SO, Italy
A.O. Ospedale di Circolo di Busto Arsizio, Busto Arsizio, VA, Italy
Ospedale di Circolo e Fondazione Macchi, Varese, VA, Italy
Casa di Cura Dott. Pederzoli, Peschiera del Garda, VR, Italy
AUSL Viterbo - Ospedale di Belcolle, Viterbo, VT, Italy
Contact Details
Name: Marco Platania, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandro Bertolini, MD
Affiliation: A.O. Valtellina e Valchiavenna - Ospedale di Sondrio
Role: PRINCIPAL_INVESTIGATOR
Name: Andrea De Monte
Affiliation: A.O. Ospedale di Circolo di Melegnano - P.O. Vizzolo Predabissi
Role: PRINCIPAL_INVESTIGATOR
Name: Luigi Cavanna, MD
Affiliation: AUSL Piacenza - Ospedale Guglielmo da Saliceto
Role: PRINCIPAL_INVESTIGATOR
Name: Marco Bregni, MD
Affiliation: A.O. Ospedale di Circolo di Busto Arsizio
Role: PRINCIPAL_INVESTIGATOR
Name: Yasmina Modena, MD
Affiliation: Azienda Ulss18 - Ospedale S.M. della Misericordia - Rovigo
Role: PRINCIPAL_INVESTIGATOR
Name: Fabrizio Nelli, MD
Affiliation: AUSL Viterbo - Ospedale di Belcolle
Role: PRINCIPAL_INVESTIGATOR
Name: Daniele Pozzessere, MD
Affiliation: Azienda USL 4 Prato - O.C. Misericordia e Dolce
Role: PRINCIPAL_INVESTIGATOR
Name: Hector Soto Parra, MD
Affiliation: A. Ospedaliero-Universitaria Policlinico Vittorio Emanuele - Catania
Role: PRINCIPAL_INVESTIGATOR
Name: Anna Paola Fraccon, MD
Affiliation: Casa di Cura Dott. Pederzoli - Peschiera del Garda
Role: PRINCIPAL_INVESTIGATOR
Name: Saverio Cinieri, MD
Affiliation: ASL Brindisi - Stabilimento Ospedaliero Di Summa-Perrino
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandro Del Conte, MD
Affiliation: A.O. Santa Maria Degli Angeli - Pordenone
Role: PRINCIPAL_INVESTIGATOR
Name: Vittorio Gebbia, MD
Affiliation: Casa di Cura La Maddalena - Palermo
Role: PRINCIPAL_INVESTIGATOR
Name: Manlio Mencoboni, MD
Affiliation: A.O. Villa Scassi - Genova
Role: PRINCIPAL_INVESTIGATOR
Name: Silvia Vattemi, MD
Affiliation: ASP di Bolzano - Comprensorio sanitario di Bolzano
Role: PRINCIPAL_INVESTIGATOR
Name: Mario Saverio Fumanò, MD
Affiliation: Ospedale Morelli - Sondalo
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Verderame, MD
Affiliation: A.O.V. Cervello - Palermo
Role: PRINCIPAL_INVESTIGATOR
Name: Luciana Irtelli, MD
Affiliation: Ospedale Civile SS. Annunziata - Chieti
Role: PRINCIPAL_INVESTIGATOR
Name: Graziella Pinotti, MD
Affiliation: Ospedale di Circolo e Fondazione Macchi, Varese
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Febbraro, MD
Affiliation: Ospedale Sacro Cuore di Gesù Fatebenefratelli - Benevento
Role: PRINCIPAL_INVESTIGATOR
Name: Rosa Rita Silva, MD
Affiliation: ASUR Marche Area Vasta 2 - Ospedale E. Profili - Fabriano (AN)
Role: PRINCIPAL_INVESTIGATOR
Name: Gabriella Farina, MD
Affiliation: A.O. Fatebenefratelli ed Oftalmico - Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Pazzola, MD
Affiliation: Ospedale Civile SS. Annunziata - Sassari
Role: PRINCIPAL_INVESTIGATOR
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