Back to resultsLate Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
Primary Purpose
Low Grade Gliomas
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Grade Gliomas focused on measuring proton radiation therapy, photon radiation therapy
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
- Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
- KPS of 70 or greater
- 18 years of age or older
- Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
- Must be able to speak and comprehend English
Exclusion Criteria:
- Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
- Prior history of cranial irradiation
- Pregnancy at the time of radiation treatment
- Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
- Comorbid illness or reason to suggest a life expectancy of less than 5 years
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton Radiation Therapy
Arm Description
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
Outcomes
Primary Outcome Measures
Number of Participants With Late Effects > 3 Months Post RT
Secondary Outcome Measures
Percentage of Participants With Progression Free Survival
Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
Percentage of Participants With Overall Survival
Percentages were estimated by Kaplan Meier
Full Information
NCT ID
NCT00681473
First Posted
May 19, 2008
Last Updated
January 24, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00681473
Brief Title
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
Official Title
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Gliomas
Keywords
proton radiation therapy, photon radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton Radiation Therapy
Arm Type
Experimental
Arm Description
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation Therapy
Intervention Description
Once daily, Monday through Friday, for 6 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Late Effects > 3 Months Post RT
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Progression Free Survival
Description
Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
Time Frame
At 1, 3, and 5 years
Title
Percentage of Participants With Overall Survival
Description
Percentages were estimated by Kaplan Meier
Time Frame
At 1, 3, and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
KPS of 70 or greater
18 years of age or older
Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
Must be able to speak and comprehend English
Exclusion Criteria:
Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
Prior history of cranial irradiation
Pregnancy at the time of radiation treatment
Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
Comorbid illness or reason to suggest a life expectancy of less than 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen A. Shih, MD, MS, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
We'll reach out to this number within 24 hrs