drugset / Trial / NCT04829097
Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma
Phase 3
Unknown
80 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |