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

Summary

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.

Conditions

• Glioblastoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo standard-dose 3D-CRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo standard-dose IMRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo dose-escalated and -intensified photon IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Photon Beam Radiation Therapy

Undergo dose-escalated and -intensified photon IMRT

RADIATION

Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Minesh P Mehta · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-04

Primary Completion

2025-07-07

Completion

2026-12-31

Countries

• United States
• Canada

Study Locations