Study on Chemoradiation Before Surgery for Treatable Glioblastoma

Sponsor: Geisinger Clinic

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04209790

Provider View

This clinical trial is exploring whether giving chemotherapy and radiation before surgery can help control glioblastoma, a type of brain cancer, more effectively. The study aims to see if this approach can improve outcomes for patients by reducing the chance of cancer returning.

Patient Parameters

Program Overview

This study is investigating a new approach to treating glioblastoma, a type of brain cancer, by using chemotherapy and radiation before surgery. The goal is to see if this method can better control the cancer and improve patient outcomes, as this type of cancer often returns after treatment. The study will proceed in two phases to determine if this new treatment approach is promising enough to be compared against the standard treatment in a larger trial.

Description

The study is testing a new treatment method where chemotherapy and radiation are given before surgery to treat glioblastoma, a type of brain cancer. This approach has shown success in controlling cancer in other types, like head and neck or bladder cancers, by improving survival rates and preserving organs.

The study will be conducted in two phases. The current standard treatment for glioblastoma offers a progression-free survival of about 6-8 months. This new approach aims to extend that to 11-12 months, based on previous studies. The hope is to reduce the rate of cancer returning from 50% to 25% and improve the time patients remain cancer-free from 50% to 75%.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed glioblastoma confirmed by lab tests.
  • Suitable for partial or full surgical removal of the tumor.
  • Good overall health with a performance status score above 70.
  • No issues preventing chemotherapy and radiation treatment.
  • Recent blood tests showing adequate bone marrow function:
    • Neutrophil count of at least 1,500 cells/mm3.
    • Platelet count of at least 100,000 cells/mm3.
    • Hemoglobin level of at least 8.0 g/dl (transfusions allowed to meet this level).
  • Recent liver function tests within normal limits:
    • ALT and AST levels no more than 3 times the normal limit.
    • Bilirubin level no more than 1.5 times the normal limit.
  • Negative pregnancy test for women who can become pregnant.
  • Ability to undergo MRI scans with contrast.

Exclusion Criteria

  • Glioblastoma that has returned, cannot be surgically removed, or is in multiple locations.
  • Cancer that has spread to other parts of the body.
  • Previous radiation or chemotherapy for brain or head and neck cancers (except for certain other cancers).
  • Pregnant or breastfeeding women, and those not using effective contraception.
  • Participation in another clinical trial within the last 30 days.
  • Inability to have an MRI scan due to safety concerns.
  • Severe health conditions, such as:
    • Recent heart attack or severe heart failure.
    • Serious wounds or infections.
    • Liver or kidney failure.
    • Severe lung disease or immune system disorders.
    • Active connective tissue disorders like lupus.
    • End-stage kidney disease.
    • Any other major health issues that could interfere with the study.

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