New target method for treating high-grade glioma patients
A Novel Target Delineation Scheme Based on RTOG(Radiation Therapy Oncology Group) and EORTC(European Organisation for Research and Treatment of Cancer) Guidelines Impact on Survival Time and Radiotherapy Complications in High-grade Glioma Patients: a Single-center Randomized Single-blind Clinical Trial
This study tests a new way of targeting radiation treatment for patients with high-grade glioma to see if it helps them live longer without their cancer getting worse and reduces side effects compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06215495 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel target delineation scheme for radiotherapy in patients with high-grade glioma. Participants will be randomly assigned to either the new target method or the standard EORTC target method after surgery. Both groups will receive temozolomide during and after radiotherapy. The primary goals are to assess improvements in progression-free survival and reductions in radiation-related complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with high-grade glioma who have undergone successful surgical resection.
Not a fit: Patients with low-grade glioma or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance survival rates and minimize side effects for patients with high-grade glioma.
How similar studies have performed: While similar approaches have been explored, this specific target delineation scheme is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 type of malignant cancers 3. not having been performed gross total resection of tumor 4. Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness； 5. Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia; 6. Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment) 7. Unable to perform brain magnetic resonance imaging; 8. Allergic to CT contrast agent, unable to perform enhanced CT examination; 9. Remote transfer; 10. Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma
Where this trial is running
Guangzhou
- southern medical university affiliated Zhujiang Hospital — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Yujing Tan, Doctor — +8613560347303
- Study coordinator: Yujing Tan, Doctor
- Email: tanyujing-1981@163.com
- Phone: +8613560347303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.