MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer (MILES-3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples Identifier:
First received: February 26, 2010
Last updated: November 25, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Drug: Gemcitabine
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • worst grade toxicity per patient [ Time Frame: at end of each 3 week cycle of chemotherapy ] [ Designated as safety issue: Yes ]
    worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03

  • progression free survival [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline and 8, 21, 29, and 42 days after therapy initiated ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: after 9 and 18 weeks of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: March 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gemcitabine Drug: Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Experimental: gemcitabine + cisplatin Drug: Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles


Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01405586

Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571
Contact: Maria Carmela Piccirillo, M.D. +39 081 5903615

  Show 50 Study Locations
Sponsors and Collaborators
National Cancer Institute, Naples
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
  More Information

Responsible Party: National Cancer Institute, Naples Identifier: NCT01405586     History of Changes
Other Study ID Numbers: MILES-3  2009-013540-36 
Study First Received: February 26, 2010
Last Updated: November 25, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016