N/A
N=90
Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma
Brain Tumor · Medulloblastoma · Pineoblastoma
Bottom Line
View on ClinicalTrials.gov: NCT01063114 ↗Enrolled (actual)
90
Serious AEs
10.0%
Results posted
Aug 2025
Primary outcome: Primary: Cumulative Incidence of Ototoxicity — 26; 27 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- proton beam radiation (Radiation)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Ototoxicity |
26; 27 | — |
| PRIMARY Endocrine Dysfunction |
46; 67 | — |
| PRIMARY Neurocognitive Effects |
102.7; 91.7 | 0.01024 sig |
| SECONDARY Progression Free Survival |
83.2; 79.6 | — |
| SECONDARY Treatment Efficiency |
— | — |
| SECONDARY Percentage of Participants Who Experienced an Acute Toxicity by Grade |
90; 84; 36; 12; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01063114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.