Status:
RECRUITING
A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial
Lead Sponsor:
Zhujiang Hospital
Conditions:
Radiation Toxicity
MRI Simulated Positioning
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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-g...
Eligibility Criteria
Inclusion
- High-grade glioma (2021 WHO grade III or IV)
- Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70
- result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential
- The patient voluntarily joined this study and signed an informed consent form
- Willing to return for follow-up
- Willing to provide tissue and blood samples for this research
- Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)
- Radiotherapy within 4-6 weeks after surgery
- No contraindications for taking temozolomide
Exclusion
- Low-grade glioma(2021 WHO grade I or II)
- had or having other type of malignant cancers
- not having been performed gross total resection of tumor
- 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；
- Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;
- 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)
- Unable to perform brain magnetic resonance imaging;
- Allergic to CT contrast agent, unable to perform enhanced CT examination;
- Remote transfer;
- Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma
Key Trial Info
Start Date :
February 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06215495
Start Date
February 18 2024
End Date
June 1 2027
Last Update
March 15 2024
Active Locations (1)
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1
southern medical university affiliated Zhujiang Hospital
Guangzhou, China