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Brief Title: Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC
Official Title: A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.
Study ID: NCT02175381
Brief Summary: The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.
Detailed Description: About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice. In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity. There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients. On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece, Heraklion, Crete, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, , Greece
401 Military Hospital of Athens, Athens, , Greece
Air Forces Military Hospital of Athens Athens, Greece, Athens, , Greece
Medical Oncology Unit NIMTS (Veterans Hospital), Athens, , Greece
Name: Lambros Vamvakas, MD
Affiliation: University Hospital of Herklion
Role: PRINCIPAL_INVESTIGATOR
Name: Athanasios Karambeazis, MD
Affiliation: Medical Oncology Unit NIMTS (Veterans Hospital)
Role: PRINCIPAL_INVESTIGATOR