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Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes


Phase 2
3 Years
25 Years
Open (Enrolling)
Both
Brain Tumor, Medulloblastoma, Pineoblastoma

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Trial Information

Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes


- Before beginning radiation therapy, participants will have scans done in order to
prepare for the radiation treatment. Doctors will use information gathered from these
scans to plan the best way to deliver radiation to the tumor.

- The following procedures will be performed either before or during the radiotherapy:
Hearing exam; neurocognitive exam; blood tests and cerebral spinal fluid test.

- Not everyone who participates in this study will receive the same amount of proton
radiation therapy. The length of time and amount of radiation received will depend
upon the condition of the participant's disease. Radiation treatment will be given
once a day, 5 days a week (Monday-Friday). The overall treatment course will be
approximately 6 weeks.


Inclusion Criteria:



- Participants must have undergone biopsy or attempted surgical resection and must have
histologically confirmed medulloblastoma or pineoblastoma.

- Participants may have had a gross total resection, sub-total resection or biopsy
only.

- For patients with prior chemotherapy, treatment must start within 35 days of
definitive surgery or as indicated if enrolled on therapeutic study

- Age range between 3 and 25 at the time of enrollment

- Life expectancy of greater than 3 months

- Blood laboratory values as outlined in the protocol

- 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:

- Patients with more than one previous chemotherapy regimen

- Patients with recurrent disease

- Patients with prior radiation therapy

- Any major uncontrolled or poorly controlled intercurrent illness that would limit
compliance with study requirements

- Pregnant women

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:

Ototoxicity

Outcome Description:

Incidence and severity of ototoxicity at three years following the completion of radiation therapy.

Outcome Time Frame:

3 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:

09-361

NCT ID:

NCT01063114

Start Date:

April 2010

Completion Date:

April 2021

Related Keywords:

  • Brain Tumor
  • Medulloblastoma
  • Pineoblastoma
  • proton beam radiation
  • Brain Neoplasms
  • Medulloblastoma
  • Pinealoma

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
Massachusetts General Hospital Boston, Massachusetts  02114-2617