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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.


Phase 3
70 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Cesare Gridelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

Authority:

Italy: Ethics Committee

Study ID:

MILES-3

NCT ID:

NCT01405586

Start Date:

March 2011

Completion Date:

June 2015

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • elderly
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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