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

NCT06215495 · tracked via the Priya Life Science China tracker

Sponsor

Zhujiang Hospital

Phase

Not applicable

Started

2024-02-18

Last updated

2024-03-15

Condition(s) studied

Radiation ToxicityMRI Simulated PositioningHigh Grade GliomaProgression-free SurvivalOverall Survival

Investigational drug(s) / intervention(s)

reduced target volumeEORTC (European organisation for research and treatment of cancer) target volume

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

EORTC (European organisation for research and treatment of cancer) target volume: delineate according to EORTC guideline

Study 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-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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

progression-free survival — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
confirm if the participant's cancer progresses or he/she dies every time back to the hospital during screening and follow-up

Trial sites (1)

Facility	City	Region	Status
southern medical university affiliated Zhujiang Hospital	Guangzhou	China	Recruiting

More Zhujiang Hospital trials in China

Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting Recruiting

Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS Starting soon

Hemodynamic Study of In-Stent Stenosis(I) After Flow Diverter(F) Based on 3D-DSA(D) Combined With TCCD(T) Recruiting

Clinical Study on the Safety and Efficacy of PID23 Injection in Patients With Relapsed/Refractory Acute Leukemia Starting soon

Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma Recruiting

Other trials for the same condition

Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma Starting soon

Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer Active, not recruiting

Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac) Recruiting

Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors Recruiting

The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06215495 on ClinicalTrials.gov ↗ ← All trials in China