Description Module

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: 2025-12-24 @ 10:29 PM
Ignite Modification Date: 2025-12-24 @ 10:29 PM
NCT ID: NCT00434135
Brief Summary: The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL
Detailed Description: Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 \& 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.
Study: NCT00434135
Study Brief:
Protocol Section: NCT00434135