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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06215495
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zhujiang Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yujing Tan, Doctor
Principal Investigator Affiliation	+8613560347303
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Radiation Toxicity, MRI Simulated Positioning, High Grade Glioma, Progression-free Survival, Overall Survival

Arms & Interventions

Arms

Experimental: reduced CTV (clinical target volume) and PTV (planning target volume)

Active Comparator: EORTC CTV (clinical target volume) and PTV (planning target volume)

Interventions

Radiation: - reduced target volume

Delineate residual tumor(GTVp) and tumor bed(GTVtb) on enhanced contrast CT-MRI(T2 fluid attenuated inversion recovery, T2 FLAIR) fusion images. GTVtb and GTVp are expanded by 1cm to CTV_6000. The clinical target volume_6000 cGy (CTV_6000) is partially reduced beyond the skull and midline. According to the CT-MRI(T2 FLAIR) fusion images, the edema area that cannot be seen on contrast-enhanced CT and only can be seen on MRI should be included. If CTV_6000 includes thalamus, basal ganglia, brainstem or motor cortex, dose of these areas will be limited no more than 54Gy

Radiation: - EORTC (European organisation for research and treatment of cancer) target volume

delineate according to EORTC guideline

Contact a Trial Team

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International Sites

Guangzhou, China

Status

Recruiting

Address

southern medical university affiliated Zhujiang Hospital

Guangzhou, ,

Site Contact

Yujing Tan, Doctor

[email protected]

+8662782356

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