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NCT Number: NCT01063114

Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

There are two types of external radiation treatments (proton beam and photon beam). As part of the participant's treatment, they will receive radiation to the entire central nervous system (CNS); this is known as craniospinal irradiation (CSI). In the past, photon radiation therapy has been used for CSI. In this study we will be examining the effects of proton beam radiation therapy. Studies have suggested that this kind of radiation can cause less damage to normal tissue than photon radiation therapy. The physical characteristics of proton beam radiation let the doctor safely deliver the amount of radiation delivered to the tumor that is normally delivered through standard therapy but spare more normal tissue in the process.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Medulloblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Pinealoma Pineoblastoma

Age range

3 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 no 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 or progressive disease after one or more regimens of pre-radiation chemotherapy
  • Patients with prior radiation therapy
  • Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements
  • Pregnant women

Treatment and study plan

Proton beam radiation

Radiation

Given once a day, 5 days a week (Monday-Friday)

Primary outcomes

  1. Cumulative Incidence of Ototoxicity

    Time frame: 3- and 5- years post radiation treatment

    Cumulative incidence (estimated percentage participants) who experienced ototoxicity defined as either grade 3 or 4 hearing loss in either ear after the completion of radiation therapy in the overall participant population. Cumulative incidence and 95% confidence intervals are shown at 3- and 5-years post RT (radiation treatment)

  2. Endocrine Dysfunction

    Time frame: 3- and 5- years post radiation treatment

    Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.

  3. Neurocognitive Effects

    Time frame: Baseline and Follow-up (median of 6 years)

    Difference in Full-Scale Intelligence Quotient (FSIQ) between baseline and latest follow-up neurocognitive test. Tests used include WISC (Wechsler Intelligence Scale for Children) IV, WISC V, WAIS (Wechsler Adult Intelligence Scale) III, WAIS IV. The test measures the FSIQ of children through four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale with an average score of 100 and standard deviation of 15. Higher scores represent higher intelligence and lower scores represent reduced intelligence.

Secondary outcomes

  1. Progression Free Survival

    Time frame: 3- and 5-years post radiation treatment

    3- and 5-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.

  2. Treatment Efficiency

    Time frame: 2 years

    To modify the speed of treating patients requiring cranial spinal irradiation (CSI) and improve the safety of treating patients under anesthesia

  3. Percentage of Participants Who Experienced an Acute Toxicity by Grade

    Time frame: 3 months after radiation therapy

    All patients shall be assessed for acute toxicity on a weekly basis during craniospinal irradiation (CSI). Percentage of participants who experienced an acute toxicity by grade. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2010
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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