A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind
The main question it aims to answer are: 1. whether the new target delineation scheme can improve Progression-free Survival 2. whether it can reduce the incidence of radiation complications in high-grade glioma patients. Participants in trial group will be performed radiotherapy of new target delineation method after t
| Condition(s) | Radiation Toxicity, MRI Simulated Positioning, High Grade Glioma, Progression-free Survival, Overall Survival |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The main question it aims to answer are: 1. whether the new target delineation scheme can improve Progression-free Survival 2. whether it can reduce the incidence of radiation complications in high-grade glioma patients. Participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 \~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total. |
| Who can participate | Inclusion Criteria: 1. High-grade glioma (2021 WHO grade III or IV) 2. Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70 3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential 4. The patient voluntarily joined this study and signed an informed consent form 5. Willing to return for follow-up 6. Willing to provide tissue and blood samples for this research 7. Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency) 8. Radiotherapy within 4-6 weeks after surgery 9. No contraindications for taking temozolomide Exclusion Criteria: 1. Low-grade glioma(2021 WHO grade I or II) 2. had or having other |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Zhujiang Hospital |
| Locations | Guangzhou, China |
| Start date | 2024-02-18 |
| NCT ID | NCT06215495 |
| Official listing | https://clinicaltrials.gov/study/NCT06215495 |