This clinical trial compares advanced magnetic resonance imaging (MRI)-based adaptive radiation therapy to current standard of care (SOC) non-adaptive radiation therapy in treating patients with newly diagnosed high grade glioma (HGG). Treatment of newly diagnosed HGG includes surgical removal of tumor, radiation therapy, and chemotherapy with the drug temozolomide. Despite these aggressive measures, nearly all cases come back (recur), and recurrences are typically within the area where radiation therapy was delivered. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Advanced MRI-based adaptive radiation therapy may be more effective than current SOC non-adaptive radiation therapy in predicting and treating the area of disease progression or recurrence in patients with HGG.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06108206.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Contact: Tony J. C. Wang
Phone: 212-305-9097
PRIMARY OBJECTIVES:
I. To compare the accuracy and volume of the current standard of care volume definition with an MRI-based adaptive plan in predicting the location of disease progression in patients with high-grade glioma.
II. Assess the prognostic and predictive value of highly-diffusion weighted and perfusion-weighted imaging in estimating progression-free and overall survival in patients with high-grade glioma.
OUTLINE:
Patients receive SOC temozolomide (TMZ) on study and undergo radiation therapy once daily (QD) for 15-33 fractions per SOC. Patients undergo MRI at baseline within 2 weeks of starting treatment and on fraction 4 or 5 of week 1, between fractions 6-10 of week 2, between fractions 11-15 of week 3, between fractions 16-20 of week 4, on fractions 24 or 29 of week 5, and on fraction 30 or 33 of week 6 of radiation therapy. After at least 5 days after week 3 MRI, patients also receive gadobutrol intravenously (IV) prior to MRI on week 4. Additionally, patients undergo SOC computed tomography (CT) on study.
After completion of study intervention, patients are followed for up to 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorTony J. C. Wang
