Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Overview
- Phase
- Phase 2
- Intervention
- Temozolomide
- Conditions
- Low-grade Glioma
- Sponsor
- West China Hospital
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
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 with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.
Investigators
Xingchen Peng
PhD, Associate Professor
West China Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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. -
Arms & Interventions
RT+TMZ
Intervention: Temozolomide
RT+TMZ
Intervention: intensity modulated radiation therapy
RT
Intervention: intensity modulated radiation therapy
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: up to 120 months
Our primary outcome is progression-free survival which is calculated from the date of randomization to the date of first reported disease progression or the date of death.