A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial

Launched by ZHUJIANG HOSPITAL · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for targeting radiation treatment in patients with high-grade glioma, a type of brain cancer. The main goals are to see if this new method can help patients live longer without their cancer getting worse (called progression-free survival) and if it can lower the risk of side effects from radiation treatment. Participants will be divided into two groups: one will receive the new radiation targeting method, while the other will receive the standard method. Both groups will also take a medication called temozolomide during and after their radiation therapy to help fight the cancer.

To be eligible for this trial, participants should be adults aged 18 to 65 who have high-grade glioma and have recently undergone surgery to remove the tumor. They should also be able to understand and sign a consent form, return for follow-up visits, and provide samples of blood and tissue for research. Participants can expect to undergo radiation therapy starting 4 to 6 weeks after their surgery, along with regular check-ups to monitor their progress. It’s important for potential participants to discuss any health concerns with their doctor before considering joining the trial.

Gender

ALL

Eligibility 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