Stupp Trial — Radiotherapy Plus Concomitant and Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (EORTC 26981/22981-NCIC CE.3)

Phase 3 · 2005 · Glioblastoma

Design

Randomized trial of postoperative radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide.

Population

Newly diagnosed, histologically confirmed glioblastoma in adults aged 18-70 with good performance status.

Primary Endpoint

overall survival (OS)

Key Result

5-year analysis: median OS 14.6 vs 12.1 mo (HR 0.63); 2-year OS 27.2% vs 10.9%; 5-year OS 9.8% vs 1.9% — establishing a long-term survival tail, greatest in MGMT-methylated tumors.

Guideline Impact

NCCN standard of care (Stupp regimen) for newly diagnosed glioblastoma