Study on Using Pulsed Reduced Dose Radiotherapy for Initial Treatment of Glioblastoma

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04747145

Provider View

This clinical trial is exploring whether a new type of radiation therapy, called pulsed reduced dose radiotherapy (pRDR), can help control glioblastoma, a type of brain cancer, when used as the first treatment after surgery.

Patient Parameters

Program Overview

The main goal of this study is to see if using pulsed reduced dose radiotherapy (pRDR) instead of standard radiation can slow down the progression of glioblastoma, a type of brain cancer. This study is for patients who have had surgery to remove as much of the tumor as possible and are planning to receive chemotherapy and radiation therapy.

Description

This study is a phase 2 trial conducted at a single center to test the effectiveness of pulsed reduced dose-rate radiotherapy in treating glioblastoma after surgery. The main focus is to see if this approach can keep the cancer from progressing for at least six months. Patients who have been diagnosed with glioblastoma and are scheduled for six weeks of combined chemotherapy and radiation, followed by six to twelve months of additional chemotherapy, will be considered for participation after their surgery.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent before any study-related procedures that are not part of standard care.
  • Must be 18 years or older.
  • Must have a new diagnosis of glioblastoma confirmed by lab tests.
  • Tumor must be located in the upper part of the brain.
  • Must have recovered from surgery to remove the tumor, whether it was fully removed, partially removed, or only a biopsy was done.
  • Must be planning to receive standard chemotherapy and radiation therapy after surgery.
  • Must be planning to receive additional chemotherapy after the initial treatment.
  • Must have had a test to check for a specific gene marker in the tumor tissue before joining the study.
  • Must have a performance status score of 70 or higher, indicating the ability to care for oneself.
  • Must have a life expectancy of at least three months.
  • Must start the study at least three weeks after brain surgery.
  • Must have stable or decreasing doses of steroids for the past week, if applicable.
  • Must have adequate blood cell counts and bone marrow function.
  • Female participants must meet specific criteria regarding pregnancy and contraception.
  • Male participants must agree to use effective contraception or abstain from sexual activity during the study and for four months after the last treatment.

Exclusion Criteria

  • Cannot have had another invasive cancer within the past three years, except for certain skin cancers.
  • Cannot have recurrent or multiple gliomas.
  • Cannot have cancer that has spread to other parts of the body.
  • Cannot have had previous radiation to the head or neck that overlaps with the current treatment area.
  • Cannot have severe, active health conditions such as recent heart attacks, severe heart failure, or connective tissue disorders that increase the risk of radiation side effects.
  • Cannot have end-stage kidney disease.
  • Cannot be pregnant or unwilling to use contraception, as the treatment may harm an unborn baby.
  • Cannot be participating in another clinical trial within 30 days before joining this study.
  • Cannot be unable to undergo MRI scans.

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