drugset
drugset / Trial / NCT02882984

Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)

NCT02882984 ↗

Phase 3 Unknown 325 enrolled Sichuan Provincial People's Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive function, quality of life (QoL) and adverse events.

Timeline

Start
2015-03
Primary completion
2020-03
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Background Erlotinib Small molecule 150 mg Oral
Background Gefitinib Small molecule 250 mg Oral
Background Icotinib Small molecule 125 mg Oral

Indications

No indication recorded.