Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00681473
First received: May 19, 2008
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Grade Gliomas |
Radiation: Proton Radiation Therapy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To characterize radiation late effects in low-grade glioma patients treated with proton radiation therapy. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To document progression free survival rates by proton radiation in patients with low-grade gliomas. [ Time Frame: TBD ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681473
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Helen A. Shih, MD, MS, MPH | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00681473 History of Changes |
| Other Study ID Numbers: | 06-195 |
| Study First Received: | May 19, 2008 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
proton radiation therapy photon radiation therapy |
Additional relevant MeSH terms:
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 22, 2013