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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405586
Recruitment Status : Active, not recruiting
First Posted : July 29, 2011
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):
National Cancer Institute, Naples

February 26, 2010
July 29, 2011
October 6, 2017
March 2011
November 2016   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01405586 on Archive Site
  • worst grade toxicity per patient [ Time Frame: at end of each 3 week cycle of chemotherapy ]
    worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
  • progression free survival [ Time Frame: every 9 weeks ]
  • quality of life [ Time Frame: baseline and 8, 21, 29, and 42 days after therapy initiated ]
  • objective response [ Time Frame: after 9 and 18 weeks of therapy ]
Same as current
Not Provided
Not Provided
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
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.
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • Drug: Gemcitabine
    1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
  • Drug: Gemcitabine
    1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
  • Drug: Cisplatin
    60 mg/m2 day 1 every 3 weeks for 6 cycles
  • Active Comparator: gemcitabine
    Intervention: Drug: Gemcitabine
  • Experimental: gemcitabine + cisplatin
    • Drug: Gemcitabine
    • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
September 2018
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
70 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
2009-013540-36 ( EudraCT Number )
Not Provided
Not Provided
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
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
National Cancer Institute, Naples
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP