MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
NCT ID: NCT01405586
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
299 participants
INTERVENTIONAL
2011-03-31
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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gemcitabine
Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
gemcitabine + cisplatin
Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles
Interventions
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Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Stage III B or Stage IV disease
* Age \> or = 70 years
* ECOG Performance status 0 or 1
* Patient at first diagnosis or with recurrence after primary surgery
* At least one target or non-target lesion according to RECIST criteria
* Life expectancy of at least 3 months
* Neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 10g/dl
* Creatinine \< 1.5 x the upper normal limit
* AST and ALT \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis)
* Bilirubin \< 1.5 x the upper normal limit
* Signed informed consent
Exclusion Criteria
* History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Symptomatic cerebral or spinal cord metastasis
* Myocardial infarct within the last 12 months
* Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
* Known or suspected hypersensitivity to any of the drugs used in the study
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent
70 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Cesare Gridelli, M.D.
Role: PRINCIPAL_INVESTIGATOR
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Second University of Naples, Italy; Chair of Medical Statistics
Locations
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Ospedale Villa Scassi
Genova, GE, Italy
Policlinico Giaccone
Palermo, PA, Italy
Azienda Ospedaliera Universitaria Senese
Siena, SI, Italy
Ospedale San Lazzaro
Alba, , Italy
Ospedale Regina Apostolorum
Albano Laziale, , Italy
AOU Ospedale Riuniti Umberto I
Ancona, , Italy
ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
Aprilia, , Italy
Ospedale Cardinale Massaia
Asti, , Italy
S. Giuseppe Moscati
Avellino, , Italy
Centro Riferimento Oncologico
Aviano, , Italy
Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Ospedale A. Cardarelli
Campobasso, , Italy
Ospedale Ramazzini di Carpi
Carpi, , Italy
Ospedale S. Spirito
Casale Monferrato, , Italy
A.O. Garibaldi Nesima
Catania, , Italy
Ospedale Mater Domini
Catanzaro, , Italy
Ospedale della Madonna della Navicella
Chioggia, , Italy
Ospedale Civile di Faenza
Faenza, , Italy
A.O.U. Arcispedale Sant'Anna di Ferrara
Ferrara, , Italy
Ospedale Don Luigi Di Liegro
Gaeta, , Italy
IRCCS San Martino -IST Genova
Genova, , Italy
Ospedale F. Veneziale
Isernia, , Italy
A.O. Vito Fazzi-Lorusso
Lecce, , Italy
Ospedale Civile di Legnano
Legnano, , Italy
Istituto Sceintifico Romagnolo
Meldola, , Italy
Ospedale L. Sacco Polo Universitario
Milan, , Italy
Ospedale San Paolo
Milan, , Italy
U.L.S.S. 13
Mirano, , Italy
Ospedale San Gerardo
Monza, , Italy
Azienda Ospedaliera Cardarelli
Napoli, , Italy
Second University of Naples
Napoli, , Italy
A.O. Università Federico II
Napoli, , Italy
AORN Ospedale dei Colli - Osp Monaldi
Napoli, , Italy
Istituto Nazionale dei Tumori
Napoli, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I
Pagani, , Italy
Casa di Cura La Maddalena
Palermo, , Italy
Ospedale Buccheri La Ferla - Fatebenefratelli
Palermo, , Italy
Fondazione Salvatore Maugeri
Pavia, , Italy
Ospedale Guglielmo d Saliceto-Piacenza
Piacenza, , Italy
Azienda Ospedaliera S. Carlo
Potenza, , Italy
Ospedale S. Maria delle Croci
Ravenna, , Italy
Ospedale Umberto I
Ravenna, , Italy
A.O. S. Camillo Forlanini
Roma, , Italy
Campus Biomedico Policlinio Universitario
Roma, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, , Italy
Ospedale S. Andrea
Vercelli, , Italy
Ospedale S. Bortolo ULSS 6
Vicenza, , Italy
ASL Viterbo - Ospedale Belcolle
Viterbo, , Italy
Countries
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Other Identifiers
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2009-013540-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MILES-3
Identifier Type: -
Identifier Source: org_study_id
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