Clinical trial · Interventional
Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma
Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
| Pineoblastoma | Pineoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proton beam radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Beam Radiation
- description
- Proton Beam Radiation
- interventionNames
- Radiation: proton beam radiation
Primary outcomes (3)
- measure
- Cumulative Incidence of Ototoxicity
- timeFrame
- 3- and 5- years post radiation treatment
- description
- 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)
- measure
- Endocrine Dysfunction
- timeFrame
- 3- and 5- years post radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVatner RE, Niemierko A, Misra M, Weyman EA, Goebel CP, Ebb DH, Jones RM, Huang MS, Mahajan A, Grosshans DR, Paulino AC, Stanley T, MacDonald SM, Tarbell NJ, Yock TI. Endocrine Deficiency As a Function of Radiation Dose to the Hypothalamus and Pituitary in Pediatric and Young Adult Patients With Brain Tumors. J Clin Oncol. 2018 Oct 1;36(28):2854-2862. doi: 10.1200/JCO.2018.78.1492. Epub 2018 Aug 17. PMID 30118397