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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Willing to return for follow-up

• Willing to provide tissue and blood samples for this research

• Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)

• Radiotherapy within 4-6 weeks after surgery

• No contraindications for taking temozolomide

Locations
Other Locations
China
southern medical university affiliated Zhujiang Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Yujing Tan, Doctor
tanyujing-1981@163.com
+8613560347303
Time Frame
Start Date: 2024-02-18
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 88
Treatments
Experimental: reduced CTV (clinical target volume) and PTV (planning target volume)
Active_comparator: EORTC CTV (clinical target volume) and PTV (planning target volume)
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov