drugset / Trial / NCT04316039

Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

NCT04316039

Phase 2/3 Recruiting 250 enrolled West China Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.

Timeline

Start
2018-04-10
Primary completion
2023-04-10
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications