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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00732303
Brief Summary:
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.
Detailed Description:
OUTLINE: This is a multi-center study.
* Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Performance Status: ECOG performance status 2
Life Expectancy: Not specified
Hematopoietic:
* Platelets ≥ 100 K/mm3
* Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
Hepatic:
* Aspartate transaminase (AST) ≤ 2.5 x ULN.
* Alanine transaminase (ALT) ≤ 2.5 x ULN.
* Total bilirubin ≤ 1.5 x ULN
Renal:
* Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
Cardiovascular:
* No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
Pulmonary:
* Forced expiratory volume in 1 second (FEV1) greater than 1L
Study:
NCT00732303
Study Brief:
Protocol Section:
NCT00732303