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

Phase 2

Recruiting

• Conditions: Low-grade Glioma
• Interventions: Drug: Temozolomide; Radiation: intensity modulated radiation therapy

• Registration Number: NCT04316039
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-10
• Status Verified: 2020-03
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Study First Posted: 2020-03-20
• Last Update Posted: 2020-03-20
• Primary Completion: 2023-04-10
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RT+TMZ	intensity modulated radiation therapy	-
RT	intensity modulated radiation therapy	-
RT+TMZ	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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.

Trial Locations

Locations (1)

Xingchen Peng; 🇨🇳 Chengdu, Sichuan, China