drugset / Trial / NCT00497250

Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy

NCT00497250

Phase 1 Unknown 32 enrolled Fudan University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the tolerability and the maximum tolerated dose of Conformal or Intensity-Modulated Radiotherapy when given in combination with gefitinib 250mg in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy. Secondary objectives of the study are to obtain the preliminary information on efficacy after concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria. To determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.

Timeline

Start
2007-07
Primary completion
2009-03
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg Oral