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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01258127
Brief Summary:
The main purpose of this randomized phase II trial is to evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely resected non-small cell lung cancer (NSCLC).
Detailed Description:
Pemetrexed, a multi-target folate antimetabolite, shows clear activity in non-small cell lung cancer (NSCLC). In a phase III study for patients with previously treated advanced NSCLC, the efficacy of single-agent pemetrexed, as determined by overall survival, was similar to that of docetaxel. (Hanna et al, 2004) The combination of carboplatin and pemetrexed has been of particular interest because it has demonstrated both good efficacy and a tolerable side effect profile. Phase I studies evaluated pemetrexed plus carboplatin in patients with malignant pleural mesothelioma, showed the regimen was efficacious and well tolerated. (Hughes et al, 2002) The combination of oxaliplatin and pemetrexed was compared with carboplatin and pemetrexed as first-line therapy for advanced NSCLC in a randomized phase II study. Response rates were 27 and 33%, respectively, and not statistically different. Toxicity in the carboplatin/pemetrexed arm was low, this doublet can be delivered easily and is well tolerated. Dose reductions occur only in 3.7% cycles. (Scagliotti et al, 2005) Therefore, it seems reasonable to test a less toxic regimen in patients with NSCLC after complete (R0) resection of the tumor, where reduced toxicities might improve the feasibility of drug delivery, compliance and the convenience of treatment for the patient and hence perhaps improve survival. The main purpose of this randomized phase II trial is to evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely resected NSCLC.
Study:
NCT01258127
Study Brief:
Protocol Section:
NCT01258127