Study on High-Dose Radiation Therapy with Temozolomide for Newly Diagnosed Glioblastoma

Program Overview

This study is testing whether higher doses of radiation therapy, using either photon or proton beams, are more effective than standard doses when combined with the drug temozolomide in treating glioblastoma, a type of brain cancer. Radiation therapy uses high-energy rays to kill cancer cells, and temozolomide may make these cells more sensitive to radiation. The study will help determine if the higher dose treatments can improve survival and reduce damage to normal tissue compared to standard treatments.

Description

The main goal of this study is to see if higher doses of radiation therapy, using either photon or proton beams, along with the drug temozolomide, can improve survival in patients with newly diagnosed glioblastoma compared to standard-dose radiation therapy. The study will also compare the side effects and impact on cognitive function between the different treatments.

Patients will be divided into two groups based on the type of radiation center they attend. Each group will have two treatment options:

• Group I (Photon IMRT Centers):

  • Arm A1: Standard-dose photon radiation therapy.
  • Arm B: High-dose photon radiation therapy.

• Group II (Proton Centers):

  • Arm A2: Standard-dose photon radiation therapy.
  • Arm C: High-dose proton radiation therapy.

All patients will receive temozolomide during radiation therapy and continue taking it in cycles after radiation is completed, as long as the disease does not progress and side effects are manageable.

After treatment, patients will have regular follow-up visits to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Locations