Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

• Status: Recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West China Hospital
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

1. Newly diagnosed supratentorial WHO grade II gliomas;

2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;

3. Karnofsky performance score (KPS) ≥ 60;

4. No more than moderate neurologic symptoms and signs;

5. The interval between surgery and randomization is less than 12 weeks;

6. Have signed the consent form. -

Exclusion Criteria:

1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system;

2. Have received prior radiation therapy to the head and neck region;

3. Have received prior chemotherapy;

4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;

5. Prior malignancy's disease-free survival less than 5 years;

6. Have active infection;

7. Patients are pregnant or breast-feeding. -