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A Phase II Study of Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation: An Assessment of Long Term Neurocognitive, Neuroendocrine Adn Ototoxicity Outcomes


Phase 2
1 Year
25 Years
Open (Enrolling)
Both
Brain Tumor, Low Grade Glioma, Astrocytoma, Ependymoma, Ganglioglioma

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Trial Information

A Phase II Study of Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation: An Assessment of Long Term Neurocognitive, Neuroendocrine Adn Ototoxicity Outcomes


- Participants will receive proton radiotherapy at the Francis H. Burr Proton Therapy Center
which is located at the Massachusetts General Hospital. They will receive the proton
radiotherapy 5 days per week. The number of weeks the participant will be receiving proton
radiotherapy depends upon the tumor type and location and how well they are tolerating the
treatment. Participant's will have a physical exam weekly during proton radiotherapy
treatment.


Inclusion Criteria:



- Biopsy proven low grade glioma or astrocytoma, ependymoma, craniopharyngioma,
meningioma, neurocytoma, medulloblastoma or gangliogliomas or other rare tumor
requiring tumor bed or tumor irradiation. Patients with a presumed diagnosis of
optic glioma or gliomas based on imaging and clinical characteristics will also be
allowed on this trial.

- Patients with biopsy proven high grade glioma (excluding GBM) and a gross total
resection and patients with non-disseminated atypical teratoid rhabdoid (ATRT) may
also be included.

- Pathologic diagnosis must be based on pathology or pathology review by Department of
Pathology at MGH or another DF/HCC institution.

- Age between 1-25 years.

- Life expectancy of greater than 1 year.

- ECOG Performance Status 0, 1, 2 or 3 or Lansky performance status 30 or greater.

- Girls and women of child-bearing potential and men must agree to use adequate
contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

- Participants who have had radiotherapy to the site to be treated.

- Participants with known spinal or distant metastases. Patients with ependymoma,
medulloblastoma or germinoma must have metastatic workup including spine MRI to rule
out metastases.

- Uncontrolled intercurrent illness that would limit compliance with study
requirements.

- Pregnant or breastfeeding women.

- Patients who cannot participate in contributing to the neurocognitive outcomes due to
severe neurologic impairment or language barrier (ie not English or Spanish speaking)
will be excluded from this study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Endocrine dysfunction

Outcome Description:

To describe the incidence of endocrine dysfunction (neuroendocrine and end organ defects) at 3 and 5 years after radiotherapy.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Torunn I. Yock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-206

NCT ID:

NCT01288235

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Brain Tumor
  • Low Grade Glioma
  • Astrocytoma
  • Ependymoma
  • Ganglioglioma
  • proton radiotherapy
  • Astrocytoma
  • Brain Neoplasms
  • Ependymoma
  • Glioma
  • Ganglioglioma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617