New target method for treating high-grade glioma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.