Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

Phase 2 Completed 65 enrolled Chinese Academy of Medical Sciences Cancer Foundation, China · collab

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

Timeline

Start: 2011-10
Primary completion: 2015-11
Completion: 2015-11

Outcome

Met primary endpoint

paper could significantly extend OS compared with historical controls in complex BMs. PMID 30996008 ↗

Publications

Bi N, Ma Y, Xiao J, Zhang H, Xu Y, Tian Y, Li J, Zhang Y, Liu Q, Wang K, Deng L, Wang W, Chen X, Liu F, Zhao R, Yang S, Huang X, Yi J, Hu C, Li Y. A Phase II Trial of Concurrent Temozolomide and Hypofractionated Stereotactic Radiotherapy for Complex Brain Metastases. Oncologist. 2019 Sep;24(9):e914-e920. doi: 10.1634/theoncologist.2018-0702. Epub 2019 Apr 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temozolomide	Small molecule	150 mg/m2	Oral