southern medical university affiliated Zhujiang Hospital
Guangzhou, China
Location status: Recruiting
NCT Number: NCT06215495
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Guangzhou, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
delineate according to EORTC guideline
Time frame: 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
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 year
confirm if the participant dies every time back to the hospital during screening and follow-up
Time frame: through study completion, up to 3 years
EORTC-QLQ-C30 questionnaire
Time frame: through study completion, up to 3 years
Contact information is provided by the study sponsor or research team.
Zhujiang Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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