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


N/A
18 Years
N/A
Open (Enrolling)
Both
Low Grade Gliomas

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize radiation late effects in low-grade glioma patients treated with proton radiation therapy.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Helen A. Shih, MD, MS, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-195

NCT ID:

NCT00681473

Start Date:

July 2007

Completion Date:

July 2013

Related Keywords:

  • Low Grade Gliomas
  • proton radiation therapy
  • photon radiation therapy
  • Glioma

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617