Trials / Unknown
UnknownNCT04547621
HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM
The Combination of Hypofractionated Stereotactic Radiotherapy and Chemoradiotherapy Using Intensity-Modulated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme: A Prospective, Single-Center, Single-Arm Phase II Clinical Trial
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Huashan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the safety and effectiveness of the combination of 30Gy/5fx HSRT and 20Gy/10fx IMRT adjuvant therapy. The total biological effective dose (BED) of the PTV is 72 Gy in a ratio of alpha/beta ratio of 3, which equals to the conventional 60Gy/30fx treatment. This study can provide evidence for future non-inferiority phase III randomized controlled trials. The abbreviated course of radiotherapy can reduce the treatment time by half, benefit patients, and utilize the health resource.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiation | Intensity-modulated radiotherapy 20Gy/10fx |
| DEVICE | Radiation | Hypofractionated Stereotactic Radiotherapy 30Gy/5fx |
| DRUG | Temozolomide | Temozolomide 75 mg/m2 concurrently administered with RT. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2023-01-01
- Completion
- 2024-01-01
- First posted
- 2020-09-14
- Last updated
- 2020-09-14
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04547621. Inclusion in this directory is not an endorsement.