drugset / Trial / NCT04829097

Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma

NCT04829097

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concurrent radiotherapy and chemotherapy, or neoadjuvant temozolomide combined with concurrent increased intensity-modulated radiotherapy. According to data from previous clinical trials, conventional doses of concurrent radiotherapy and chemotherapy PFS 6.9 months neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS 13.7 months, an estimated 20% leakage rate, and a total sample size of 80 patients.

Timeline

Start
2020-11-01
Primary completion
2023-11-01
Completion
2023-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications