Adults who have a recent diagnosis of glioblastoma, the most common primary brain tumor, may be eligible to enroll in a national randomized clinical trial at the University of Florida Health Proton Therapy Institute in Jacksonville, Fla. The study will compare treatment outcomes for people who have a higher radiation dose using proton therapy to those who have the standard radiation dose using a form of X-ray therapy called intensity-modulated radiation therapy (IMRT).

People with glioblastoma who are not in a study are usually treated with IMRT and temozolomide (Temodar) chemotherapy followed by Temodar chemotherapy alone. Although radiation and chemotherapy following surgery have been shown to improve survival, the outcome remains poor. Some recent studies have suggested improved survival with higher doses of radiation and Temodar with acceptable side effects.

This study will compare a higher radiation dose using proton radiation to the standard radiation dose using IMRT. Both groups will receive the standard chemotherapy, Temodar. The study will allow the researchers to better understand whether this higher dose/technique is better, the same or worse than the standard approach.

"With every person who has radiation treatment, our goal is to give the highest dose to the cancer cells while doing as little damage as possible to normal, healthy cells," said local principal investigator and UF Health Proton Therapy Institute radiation oncologist Ronny Rotondo, M.D., C.M., FRCPC. "With this study we will learn about the role proton therapy may have in safely delivering a higher dose of radiation in people who have glioblastoma."

The national study is sponsored by NRG Oncology, a nonprofit cancer clinical research organization that is funded by the National Cancer Institute. The title of the study is NRG-BN001 research study for patients with newly diagnosed glioblastoma multiforme. As a randomized trial, people will be put into one of two groups by chance via a computer program that is not controlled by the physician or the patient. Group A will receive the standard radiation dose using IMRT. Group B will receive a higher radiation dose using proton therapy. Both groups will receive the same dose of Temodar during and after their course of radiation.

In order to be eligible for participation on the NRG-BN001 study, prospective patients must be eighteen years and older and have a Karnofsky performance status of greater than or equal to 70 within 14 days prior to registration. Moreover, the glioblastoma must be limited to the supratentorial compartment without brainstem involvement. A diagnostic contrast-enhanced MRI of the brain must be performed postoperatively within 72 hours of surgery, with the residual tumor / surgical cavity measuring no greater than 5 cm in maximal diameter. Patients with recurrent / multifocal malignant gliomas or those who have received prior radiation or chemotherapy for their glioblastoma diagnosis are not eligible for this trial. Importantly, as central pathology review is mandated (with sufficient tissue for MGMT status) on this trial and patients must begin treatment within five weeks of surgery, prompt referral is essential, ideally within two weeks of surgery. For further information or to refer a patient for possible participation on this study, please visit www.floridaproton.org, or call toll-free 877-686-6009.