MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
MILES-3
Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.
2 other identifiers
interventional
299
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2011
Longer than P75 for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedMarch 24, 2023
March 1, 2023
13.7 years
February 26, 2010
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
one year
Secondary Outcomes (4)
worst grade toxicity per patient
at end of each 3 week cycle of chemotherapy
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
Study Arms (2)
gemcitabine
ACTIVE COMPARATORgemcitabine + cisplatin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Ospedale Villa Scassi
Genova, GE, 16100, Italy
Policlinico Giaccone
Palermo, PA, 90127, Italy
Azienda Ospedaliera Universitaria Senese
Siena, SI, 53100, 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, 80131, Italy
Second University of Naples
Napoli, 80131, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cesare Gridelli, M.D.
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
- PRINCIPAL INVESTIGATOR
Francesco Perrone, M.D., Ph.D
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
- PRINCIPAL INVESTIGATOR
Ciro Gallo, M.D., Ph.D
Second University of Naples, Italy; Chair of Medical Statistics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
July 29, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
March 24, 2023
Record last verified: 2023-03