At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)
In Brief
A Phase 2 clinical trial evaluating IMPT, IMRT, and 2 other interventions for Brain Cancer. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking. IMRT is the delivery of focused radiation therapy using photon beams and advanced computer planning to help shape the dose in order to give the highest possible dose to the tumor with the least dose to surrounding normal tissues. IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in order to shape the dose to the target with the least dose to surrounding normal tissues.
Study Details
Timeline
Interventions
IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.
Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.