Proton Radiation Therapy for Gliomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01358058|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2011
Last Update Posted : June 14, 2018
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.
In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
|Condition or disease||Intervention/treatment||Phase|
|Low Grade Glioma WHO Grade 3 Glioma With IDH1 Mutation WHO Grade 3 Glioma With 1p/19q Codeletion||Radiation: Proton radiation||Not Applicable|
Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.
Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: Proton radiation therapy
Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))
Radiation: Proton radiation
Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.
- Efficacy [ Time Frame: 7 years ]To assess progression free survival of this treatment program.
- Safety and Tolerability [ Time Frame: 7 years ]To assess the number of participants with late effects from radiation therapy
- Overall survival [ Time Frame: 7 years ]To assess overall survival of this treatment program.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358058
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Helen A Shih, MD||Massachusetts General Hospital|