Study on High Dose Adaptive Radiotherapy with Temozolomide for Newly Diagnosed Glioblastoma

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04574856

This clinical trial is exploring whether a more intense and targeted form of radiation therapy, combined with the drug Temozolomide, can improve survival rates in patients newly diagnosed with glioblastoma, a type of brain cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if using a more focused and stronger radiation treatment, adjusted during the therapy to target the most resistant parts of the tumor, can help patients with newly diagnosed glioblastoma live longer compared to the usual treatment with chemotherapy and radiation.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent and agree to follow study procedures.
  • Newly diagnosed with a specific type of brain cancer called glioblastoma or gliosarcoma.
  • Must have a performance status score of 70 or higher, indicating the ability to care for oneself.
  • Expected to live at least 12 more weeks.
  • Must have adequate blood cell counts and liver and kidney function based on recent tests.
  • Tumor size must be 5 cm or smaller based on specific MRI scans.
  • Must register for the study within 6 weeks of the most recent surgery.
  • Women who can become pregnant must have a negative pregnancy test and agree to use birth control during the study.

Exclusion Criteria

  • Have a recurrent brain tumor or a tumor in certain parts of the brain like the brainstem or cerebellum.
  • Have used certain treatments directly in the tumor area before.
  • Have cancer that has spread to the fluid around the brain or spinal cord.
  • Have a severe disease that needs treatment.
  • Have had another invasive cancer in the last 3 years, except for certain skin or prostate cancers.
  • Cannot have an MRI due to metal implants or other reasons.
  • Have had previous radiation to the head that overlaps with the current treatment area.
  • Have multiple separate tumor areas in the brain.
  • Are pregnant or breastfeeding.

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