Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
|ClinicalTrials.gov Identifier: NCT00681473|
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : January 9, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Low Grade Gliomas||Radiation: Proton Radiation Therapy||Not Applicable|
- Participants will receive radiation therapy for 6 weeks, given in daily doses, Monday through Friday, for a total of 30 treatments.
- A medical history and physical examination will be performed prior to the start of radiation treatment, weekly during the 6 weeks of radiation and after the finish of radiation performed at 3 and 6 months and then annually for 5 years.
- Hormonal function tests will be taken prior to the start of radiation treatment and after the finish of radiation treatment at 3 and 6 months, and annually for five years to assess the participants hormonal functions as they relate to the pituitary gland's function.
- A brain MRI will be performed prior to the start of radiation treatment and then performed at 3 and 6 months after radiation treatment then annually for 5 years.
- A neurocognitive exam will be performed prior to the start of radiation therapy, a limited exam 6 months after the completion of radiation therapy, and a complete exam annually for 5 years.
- Quality of Life and Emotional Well-Being Questionnaires will be done before radiation begins, 2 months after radiation treatment, 6 months after radiation treatment and then annually for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Proton Radiation Therapy
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
Radiation: Proton Radiation Therapy
Once daily, Monday through Friday, for 6 weeks.
- Number of Participants With Late Effects > 3 Months Post RT [ Time Frame: 5 years ]
- Percentage of Participants With Progression Free Survival [ Time Frame: At 1, 3, and 5 years ]Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
- Percentage of Participants With Overall Survival [ Time Frame: At 1, 3, and 5 years ]Percentages were estimated by Kaplan Meier
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681473
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Helen A. Shih, MD, MS, MPH||Massachusetts General Hospital|