NSCLC Clinical Trial
Official title:
A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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