NCT05600491

A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.

Detailed description

This study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Patients were treated with a standard therapy regimen (Stupp) plus early postsurgical temozolomide.

Conditions

• Anaplastic Oligoastrocytoma
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5 days. From day 29, patients were treated with a standard therapy regimen (Stupp).

Timeline

• Start date: 2015-11-08
• Primary completion: 2022-12-01
• Completion: 2025-12-01
• First posted: 2022-10-31
• Last updated: 2022-10-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study