UF Health Proton Therapy Institute opens randomized clinical trial for glioblastoma

April 1, 2015

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JACKSONVILLE, Fla. — 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 has been shown to improve survival, the outcome remains poor. There have been some recent studies which 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, MD, CM, 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.  This study is geared towards newly diagnosed glioblastoma. Recurrent tumors and patients who have received prior chemotherapy or radiation therapy for glioblastoma are not eligible.  Given patients on this trial must begin treatment within five weeks of surgery, prompt referral after surgery is essential, ideally within two weeks. For further information about this study, please call toll-free 877-686-6009.

UF Health Proton Therapy Institute has 21 active clinical studies. Approximately 98 percent of patients participate in a registry study to track outcomes following treatment and 31 percent of patients are enrolled in clinical trials. The national average of participation in a clinical trial is three percent.

The UF Health Proton Therapy Institute, opened August 14, 2006 in Jacksonville, Fla., is a cancer treatment facility that uses the most advanced technology available to treat and cure cancer. Proton therapy delivers a precise radiation treatment while destroying cancer cells and minimizing damage to healthy tissue. That reduces side effects and lessens the risk of developing complications from treatment in later life. It is especially beneficial for treating cancer in children and adults with cancers in sensitive areas like the head, neck, lung, breast, brain and prostate.

Nearly 6,000 patients from 49 states and 29 countries have received proton therapy at UF Health Proton Therapy Institute. In exit surveys, 98 percent of patients say they would recommend the facility to a family member or friend who needed radiation treatment.

UF Proton Therapy Institute is a nonprofit 501(c)3 organization affiliated with the UF College of Medicine and the UF Health Cancer Center, a Florida Cancer Center of Excellence, dedicated to delivering state-of-the-art cancer treatment and setting new standards for treating and curing cancer. The cancer treatment facility houses both conventional radiation and proton therapy, and delivers proton therapy to 110 patients a day. For more information about the UF Health Proton Therapy Institute, please visit www.floridaproton.org, or call toll-free 877-686-6009.


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