Clinical trial NCT06215495: A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial
Official title: A Novel Target Delineation Scheme Based on RTOG(Radiation Therapy Oncology Group) and EORTC(European Organisation for Research and Treatment of Cancer) Guidelines Impact on Survival Time and Radiotherapy Complications in High-grade Glioma Patients: a Single-center Randomized Single-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Toxicity
MRI Simulated Positioning
High Grade Glioma
Progression-free Survival
Overall Survival
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-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 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

Primary outcomes:
measure: progression-free survival
timeFrame: 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
Secondary outcomes:
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 3 year
measure: European organisation for research and treatment of cancer QLQ-C30 (EORTC-QLQ-C30)
timeFrame: through study completion, up to 3 years
measure: radiotherapy complication incidence
timeFrame: through study completion, up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: southern medical university affiliated Zhujiang Hospital
Study officials:
affiliation: +8613560347303
name: Yujing Tan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: