Status:
RECRUITING
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Lead Sponsor:
West China Hospital
Conditions:
Low-grade Glioma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients w...
Eligibility Criteria
Inclusion
- Newly diagnosed supratentorial WHO grade II gliomas;
- Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
- Karnofsky performance score (KPS) ≥ 60;
- No more than moderate neurologic symptoms and signs;
- The interval between surgery and randomization is less than 12 weeks;
- Have signed the consent form. -
Exclusion
- WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
- Have received prior radiation therapy to the head and neck region;
- Have received prior chemotherapy;
- Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
- Prior malignancy's disease-free survival less than 5 years;
- Have active infection;
- Patients are pregnant or breast-feeding. -
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04316039
Start Date
April 10 2018
End Date
December 31 2028
Last Update
March 20 2020
Active Locations (1)
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1
Xingchen Peng
Chengdu, Sichuan, China, 610041