Study on Preoperative Radiosurgery for Treating High Grade Glioma: The NeoGlioma Study

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05030298

Provider View

This clinical trial is exploring the potential benefits and side effects of using radiosurgery before surgery to treat patients with high grade glioma, a type of brain tumor. The study aims to see if this approach can better control the tumor and reduce side effects compared to traditional methods.

Patient Parameters

Program Overview

This study is investigating whether using radiosurgery before surgery can help treat high grade glioma, a serious type of brain tumor. Radiosurgery involves using special equipment to deliver a precise, high dose of radiation to the tumor, potentially killing cancer cells with fewer treatments and causing less harm to healthy tissue. The goal is to see if this method can improve tumor control and reduce side effects related to treatment.

Description

The main goal of this study is to determine if preoperative radiosurgery is safe for patients with high grade glioma, a type of brain tumor confirmed by biopsy, before they receive standard treatment.

Secondary goals include:

  • Assessing immediate side effects within four weeks after completing post-surgery radiation therapy.
  • Checking if the tumor is controlled by imaging tests 12 months after surgery.
  • Evaluating the rate of pseudoprogression, a temporary increase in tumor size, after radiation.
  • Measuring overall survival 12 months after surgery.

The study also aims to understand how radiation affects tumor repair pathways, blood vessel changes, and the immune environment around the tumor.

Participants are divided into two groups:

  • Group A: Patients will have an MRI-guided biopsy, followed by a single session of radiosurgery. Within 14 days, they will undergo surgery. After 4-6 weeks, they will receive standard radiation therapy and daily temozolomide, with or without additional tumor treating fields (TTF), as decided by their doctor.
  • Group B: Patients will have surgery first. After 4-6 weeks, they will receive standard radiation therapy and daily temozolomide, with or without TTF, as decided by their doctor.

Participants will also have MRI scans and blood samples taken, with an optional biopsy during the study. After completing treatment, they will be monitored every 2-3 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have clear evidence of high grade glioma (HGG) as determined by a specialized medical team, regardless of specific genetic markers.
  • Eligible if previously had a biopsy confirming high grade glioma and further surgery is planned.
  • Scheduled for tumor removal surgery.
  • Not at significant risk of complications from radiation before surgery.
  • No previous radiation treatment to the head.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Negative pregnancy test for women of childbearing potential within 14 days before joining the study.
  • Able to complete questionnaires independently or with help.
  • Willing to provide written consent.
  • Planning to receive follow-up radiation therapy at the study location.
  • Agree to provide tissue and/or blood samples for research.
  • Have adequate blood cell counts and hemoglobin levels as specified by recent tests.

Exclusion Criteria

  • Pregnant or nursing women.
  • Men or women of childbearing potential not using effective birth control.
  • Unwilling to participate in the study.
  • If the study doctor believes participation would be harmful.
  • Have non-MRI compatible medical devices.
  • Received cancer treatment within the last 3 months.
  • Medical reasons preventing brain surgery.
  • Have a low-grade glioma, brain metastasis, or other brain tumor, unless there is concern for transformation to a higher grade.
  • Have a spinal cord or brainstem glioma.
  • Have a large or complex tumor that makes participation unsafe.
  • Unwilling or unable to follow study procedures.

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