MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
- Conditions
- Non-small Cell Lung Cancer Stage IIIBNon-small Cell Lung Cancer Metastatic
- Interventions
- Registration Number
- NCT01405586
- Lead Sponsor
- National Cancer Institute, Naples
- Brief Summary
The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 299
- Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
- 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
- Previous chemotherapy for advanced disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gemcitabine Gemcitabine - gemcitabine + cisplatin Cisplatin - gemcitabine + cisplatin Gemcitabine -
- Primary Outcome Measures
Name Time Method overall survival one year
- Secondary Outcome Measures
Name Time Method progression free survival every 9 weeks quality of life baseline and 8, 21, 29, and 42 days after therapy initiated objective response after 9 and 18 weeks of therapy worst grade toxicity per patient at end of each 3 week cycle of chemotherapy worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
Trial Locations
- Locations (49)
ASL Viterbo - Ospedale Belcolle
🇮🇹Viterbo, Italy
Ospedale Villa Scassi
🇮🇹Genova, GE, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, SI, Italy
Policlinico Giaccone
🇮🇹Palermo, PA, Italy
Ospedale Regina Apostolorum
🇮🇹Albano Laziale, Italy
AOU Ospedale Riuniti Umberto I
🇮🇹Ancona, Italy
Ospedale San Lazzaro
🇮🇹Alba, Italy
ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
🇮🇹Aprilia, Italy
Centro Riferimento Oncologico
🇮🇹Aviano, Italy
Ospedale Senatore Antonio Perrino
🇮🇹Brindisi, Italy
Ospedale Cardinale Massaia
🇮🇹Asti, Italy
Ospedale A. Cardarelli
🇮🇹Campobasso, Italy
S. Giuseppe Moscati
🇮🇹Avellino, 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
Ospedale Don Luigi Di Liegro
🇮🇹Gaeta, Italy
A.O.U. Arcispedale Sant'Anna di Ferrara
🇮🇹Ferrara, Italy
IRCCS San Martino -IST Genova
🇮🇹Genova, Italy
AORN Ospedale dei Colli - Osp Monaldi
🇮🇹Napoli, Italy
Ospedale F. Veneziale
🇮🇹Isernia, Italy
Ospedale Civile di Legnano
🇮🇹Legnano, Italy
A.O. Vito Fazzi-Lorusso
🇮🇹Lecce, Italy
Istituto Sceintifico Romagnolo
🇮🇹Meldola, Italy
Ospedale L. Sacco Polo Universitario
🇮🇹Milano, Italy
Ospedale San Paolo
🇮🇹Milano, Italy
U.L.S.S. 13
🇮🇹Mirano, Italy
Ospedale San Gerardo
🇮🇹Monza, Italy
Azienda Ospedaliera Cardarelli
🇮🇹Napoli, Italy
Second University of Naples
🇮🇹Napoli, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
A.O. Università Federico II
🇮🇹Napoli, Italy
Istituto Nazionale dei Tumori
🇮🇹Napoli, Italy
Campus Biomedico Policlinio Universitario
🇮🇹Roma, Italy
Ospedale Guglielmo d Saliceto-Piacenza
🇮🇹Piacenza, Italy
Azienda Ospedaliera S. Carlo
🇮🇹Potenza, 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 S. Maria delle Croci
🇮🇹Ravenna, Italy
Ospedale Umberto I
🇮🇹Ravenna, Italy
A.O. S. Camillo Forlanini
🇮🇹Roma, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
🇮🇹Roma, Italy
Ospedale S. Andrea
🇮🇹Vercelli, Italy
Ospedale S. Bortolo ULSS 6
🇮🇹Vicenza, Italy