Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into
Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20
percent.
This low rate makes the investigators think about the possibility of a bias selection, due
to the existence of this exclusion criteria that do not permit to include patients with
deteriorated performance status.
In these types of patients, the toxicity is an important issue to decide the therapeutic
strategy. Gemcitabine and Docetaxel combination is very interesting because they have a
different toxicity profile. This combination has demonstrated activity in several types of
tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel;
activity and dose intensity will be the same, but toxicity will be significantly low.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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