Actively Recruiting
A Novel Target Delineation Scheme Based on RTOG and EORTC Guidelines Impact on Survival and Radiotherapy Complications in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial
Led by Zhujiang Hospital · Updated on 2024-03-15
88
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether a new method of defining the radiation target areas can improve progression-free survival and reduce radiation complications in patients with high-grade glioma. This trial compares this new target delineation approach with the standard European Organisation for Research and Treatment of Cancer (EORTC) method. The goal is to see if the new method leads to better outcomes for patients after surgery. Participants will be randomly assigned to one of two groups. The trial group receives radiotherapy using the new target delineation scheme based on CT-MRI fusion images, with careful dose limits to protect sensitive brain areas. The control group receives radiotherapy following the EORTC target delineation method. Both groups receive temozolomide chemotherapy concurrently during radiotherapy at 75 mg/m² daily, followed by six cycles of adjusted temozolomide dosing after radiotherapy. During the study, participants will be monitored for progression-free survival up to three years after randomization. Researchers will also evaluate overall survival, quality of life using the EORTC QLQ-C30 questionnaire, and the incidence of radiation-related complications. Follow-up visits and assessments will continue through study completion to track these outcomes and ensure patient safety.
CONDITIONS
Brief Title
A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-grade glioma (2021 WHO grade III or IV)
- Age between 18 and 65 years old
- Karnofsky performance status (KPS) score of 70 or higher
- Negative pregnancy test within 7 days before enrollment for women of reproductive potential
- Voluntary participation with signed informed consent
- Willingness to return for follow-up visits
- Willingness to provide tissue and blood samples for research
- Completion of surgical treatment without postoperative complications such as consciousness disorders, hematomas, lung infection, or heart failure
- Ability to receive radiotherapy within 4 to 6 weeks after surgery
- No contraindications to taking temozolomide
You will not qualify if you...
- Diagnosis of low-grade glioma (2021 WHO grade I or II)
- History or presence of other malignant cancers
- No gross total tumor resection performed
- Severe active comorbidities or systemic diseases that affect safety evaluation, including persistent infections, symptomatic heart failure, unstable angina, arrhythmia, or mental illness
- MRI showing recent or prior risk of cerebral hemorrhage or brain hernia
- Pregnancy, lactation, or pregnancy planned during the study period (from screening to 120 days after last treatment)
- Inability to undergo brain MRI
- Allergy to CT contrast agents preventing enhanced CT examination
- Remote transfer to another location
- Medical contraindications to radiation therapy such as active systemic lupus or scleroderma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiotherapy starts within 4 to 6 weeks after surgery; duration varies per treatment protocol
Participants receive radiotherapy using either a reduced clinical target volume (CTV) and planning target volume (PTV) or the EORTC guideline-based CTV and PTV.
1 baseline visit and multiple visits during radiotherapy as scheduled by treatment protocol
Duration - Up to 3 years
Participants are followed up for survival, quality of life, and radiotherapy complications for up to 3 years after randomization.
Regular follow-up visits as scheduled up to 3 years
Trial Site Locations
Total: 1 location
1
southern medical university affiliated Zhujiang Hospital
Guangzhou, China
Actively Recruiting
Research Team
Y
Yujing Tan, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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