About this trial
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
This trial does not accept healthy volunteersQualifiers
High-grade glioma (2021 WHO grade III or IV)
Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70
result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential
The patient voluntarily joined this study and signed an informed consent form
Disqualifiers
Low-grade glioma(2021 WHO grade I or II)
had or having other type of malignant cancers
not having been performed gross total resection of tumor
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;
Trial design
Parallel
Treatments tested in this trial
reduced target volume
RadiationDelineate 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
Radiationdelineate according to EORTC guideline
Treatment groups
Trial outcomes
Primary outcomes
progression-free survival
confirm if the participant's cancer progresses or he/she dies every time back to the hospital during screening and follow-up
Secondary outcomes
overall survival
confirm if the participant dies every time back to the hospital during screening and follow-up
European organisation for research and treatment of cancer QLQ-C30 (EORTC-QLQ-C30)
EORTC-QLQ-C30 questionnaire
radiotherapy complication incidence
Sponsors and contacts
Click on the lead sponsor to view all of their trials.