NCT04316039

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low-grade Glioma

Interventions

Type	Name	Description
DRUG	Temozolomide	Concurrent chemotherapy is to receive oral temozolomide, 75 mg/m2 per day, during radiation therapy. Adjuvant chemotherapy will be treated with six cycles of temozolomide, 150 to 200 mg/m2 per day for five consecutive days, repeated every 4 weeks. There is a 28-day break during radiotherapy and adjuvant temozolomide.
RADIATION	intensity modulated radiation therapy	The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).

Timeline

• Start date: 2018-04-10
• Primary completion: 2023-04-10
• Completion: 2028-12-31
• First posted: 2020-03-20
• Last updated: 2020-03-20

Locations

1 site across 1 country: China