Actively Recruiting
A Novel Target Delineation Scheme 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
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Diagnosed with 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 with reproductive potential)
- Voluntarily signed informed consent to participate
- Willing to return for follow-up visits
- Willing to provide tissue and blood samples for research
- Completed surgical treatment without postoperative complications such as consciousness disorders, hematomas, lung infection, or cardiac insufficiency
- Able to receive radiotherapy within 4 to 6 weeks after surgery
- No contraindications for taking temozolomide chemotherapy
You will not qualify if you...
- Diagnosed with low-grade glioma (2021 WHO grade I or II)
- Have had or currently have other types of malignant cancers
- Have not undergone gross total resection of the tumor
- Have severe active comorbidities or systemic diseases that make participation unsafe or evaluation unreliable, including persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmia, or mental illness
- Baseline MRI shows risk of cerebral hemorrhage or brain hernia
- Pregnant, breastfeeding, or becoming pregnant during the trial period (from screening until 120 days after last treatment)
- Unable to undergo brain MRI
- Allergic to CT contrast agents or unable to have enhanced CT scans
- Planning to transfer to another medical facility
- Medical contraindications to radiation therapy, such as active systemic lupus or scleroderma
AI-Screening
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Trial Site Locations
Total: 1 location
1
southern medical university affiliated Zhujiang Hospital
Guangzhou, China
Actively Recruiting
Research Team
Y
Yujing Tan, Doctor
CONTACT
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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