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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.
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Inclusion criteria
Histologically or cytologically confirmed diagnosis of advanced NSCLC.
Stage III with pleural effusion and stage IV.
Patients with ECOG PS 2.
Patients must have at least one measurable lesion, no previously irradiated.
Life expectancy of at least 12 weeks.
Adequate organ function according to the following criteria:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
76 participants in 1 patient group
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Central trial contact
Oscar Juan, Doctor; Vicente Alberola, Doctor
Data sourced from clinicaltrials.gov
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