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Phase II Study of Proton Radiation Therapy for Low Grade Gliomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Low Grade Gliomas, Protoplasmic Astrocytomas, Fibrillary Astrocytomas, Gemistocytic Astrocytomas, Oligoastrocytomas, Oligodendrogliomas, Other WHO Grade II/IV Gliomas

Thank you

Trial Information

Phase II Study of Proton Radiation Therapy for Low Grade Gliomas


Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be
assessed weekly for side effects. Each visit will take about 15 minutes.

Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after
their last proton radiation treatment. They will receive a physical exam, have blood tests
(about 4 teaspoons) and answer questionnaires regarding medical history, quality of life,
and emotional well-being. Subjects will also receive a neurocognitive exam (a limited exam
at 6 months, and full exam annually).


Inclusion Criteria:



- Histologically confirmed low-grade gliomas

- Subject must be indicated for radiation therapy

- Life expectancy greater than 5 years

- Willing to participate in rigorous neurocognitive evaluations at baseline and
serially following treatment

- Able to speak and comprehend English

- Recovered from adverse events due to agents administered more than 4 weeks before
entering study

- Able to undergo MRI scans

Exclusion Criteria:

- Prior cranial radiation therapy

- Chemotherapy within 4 weeks prior to entering study

- Pregnant or breastfeeding

- Known brain metastases

- Baseline neurocognitive or emotional disorders

- Uncontrolled intercurrent illness

- History of a different malignancy unless disease-free for at least 5 years

- HIV positive on antiretroviral therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy

Outcome Description:

To assess progression free survival of this treatment program.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Helen A Shih, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-439

NCT ID:

NCT01358058

Start Date:

May 2011

Completion Date:

May 2018

Related Keywords:

  • Low Grade Gliomas
  • Protoplasmic Astrocytomas
  • Fibrillary Astrocytomas
  • Gemistocytic Astrocytomas
  • Oligoastrocytomas
  • Oligodendrogliomas
  • Other WHO Grade II/IV Gliomas
  • Brain tumors
  • Radiation
  • Proton
  • Gliomas
  • Astrocytoma
  • Glioma
  • Oligodendroglioma

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617