Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00198393
Brief Summary:
Patients presenting a deterioration of the general state (performance status \[PS\] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.
Detailed Description:
Arm A Iressa 250 mg daily PROG/TOX --\> Taxotere 75 mg/m² d1 (d1=d22)
Arm B Gemzar 1250 mg/m² d1 \& d8 (d1=d22) PROG/TOX --\> Iressa 250 mg daily
Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --\> Iressa 250 mg daily
Study:
NCT00198393
Study Brief:
Protocol Section:
NCT00198393