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Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

StatusActive, Not Recruiting
PhasePhase 2
Started2014-12-04
View on ClinicalTrials.gov ↗
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

Amendment history 3 changes detected by DataLookout

2026-08-29
critical
Primary endpoint(s) modified
WasOverall survival
NowMedian Survival Time (Within Center Group)
2026-08-29
notable
Results posted: 2026-08-28
2026-08-29
notable
Interventions modified
Trial Details
NCT Number NCT02179086
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Glioblastoma
Enrollment 624 participants
Start Date 2014-12-04
Primary Completion 2025-07-07 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-28