drugset / Trial / NCT00620269

Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III

NCT00620269 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite locoregional concurrent therapy. Previously the investigators conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the encouraging activity of IP chemotherapy in the advanced stage setting, the investigators postulated that their further investigation in the stage III setting might lead to further prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with concurrent radiotherapy might lead to radiation sensitization and improved locoregional control.

Timeline

Start
2008-02
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 30 mg/m2 Intravenous
Subject Erlotinib Small molecule 150 mg Oral
Subject Irinotecan Small molecule 60 mg/m2 Intravenous
Subject Irinotecan Small molecule 65 mg/m2 Intravenous