Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00681473
First received: May 19, 2008
Last updated: April 11, 2014
Last verified: April 2014
  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: August 2015
Estimated Primary Completion Date: August 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 11, 2014
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 July 23, 2014