Status:
UNKNOWN
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Eligibility:
All Genders
70+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT01405586
Start Date
March 1 2011
End Date
November 1 2024
Last Update
March 24 2023
Active Locations (49)
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1
Ospedale Villa Scassi
Genova, GE, Italy, 16100
2
Policlinico Giaccone
Palermo, PA, Italy, 90127
3
Azienda Ospedaliera Universitaria Senese
Siena, SI, Italy, 53100
4
Ospedale San Lazzaro
Alba, Italy