Proton Beam Radiation Therapy in Treating Younger Patients with Brain Tumors
This phase II trial studies the safety and how well proton beam radiation therapy works in treating younger patients with brain tumors. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.
Inclusion Criteria
- Patients with 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 as it may be against the standard of care to biopsy some of these individuals (for example, a patient with neurofibromatosis [NF]-1 and an optic glioma will not require a biopsy for diagnosis)
- Patients with biopsy proven high-grade glioma (excluding glioblastoma multiforme [GBM]) and a gross total resection and patients with non-disseminated atypical teratoid rhabdoid (ATRT) patients may also be included
- Pathologic diagnosis must be based on pathology or pathology review by Department of Pathology at Massachusetts General Hospital (MGH) or another Dana-Farber/Harvard Cancer Center (DF/HCC) institution and must be finalized within two weeks of the radiation start date
- Life expectancy of greater than 1 year
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 or Lansky performance status of >= 30
- The effects of scatter radiation on the developing human fetus are known to be teratogenic, girls and women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of proton therapy treatment; should a patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- The patient if 18 years or more or a minor’s guardian must have the ability to understand and the willingness to sign a written informed consent document
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 magnetic resonance imaging (MRI) to rule out metastases
- Uncontrolled intercurrent illness that would limit compliance with study requirements
- Persons who are pregnant are excluded from this study because ionizing radiation is a teratogen; because there is unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy
- Patients who cannot participate in contributing to the neurocognitive outcomes due to severe neurologic impairment or language barrier will be enrolled at the discretion of the treating physician in consultation with the principal investigator (PI)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01288235.
PRIMARY OBJECTIVES:
I. To describe the incidence of endocrine dysfunction (neuroendocrine and end organ defects) at 3 and 5 years after proton radiotherapy.
II. To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.
SECONDARY OBJECTIVES:
I. To report the 3 year and 5 year local and distant disease control.
II. To assess the acute effects of treatment including hair loss in the portal.
III. To correlate dose to the cochlea to auditory function.
IV. To correlate dose to the hypothalamus and pituitary to neuroendocrine function.
V. To correlate the dose to the hippocampus, temporal lobes, and hypothalamus to specific neurocognitive tests.
OUTLINE:
Patients undergo proton beam radiation therapy using partial brain irradiation (PBI) once daily (QD), 5 days a week for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity.
After completion of treatment, patients are followed up annually for up to 5 years, with recommended annual follow up for a total of 8 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorTorunn I. Yock
- Primary ID10-206
- Secondary IDsNCI-2011-00201
- ClinicalTrials.gov IDNCT01288235