An interventional study of proton beam radiation in Brain Tumor, Medulloblastoma and Pineoblastoma, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 3 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
66 studies on the registry are indexed under Pinealoma; 11 are open to participants now.
This study's enrollment of 90 is above the median of 26 across 43 interventional studies indexed under Pinealoma.
Browse Pinealoma studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Compared within Pinealoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proton Beam Radiation
Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)
Cumulative Incidence of Ototoxicity
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)
Time frame: 3- and 5- years post radiation treatment
Endocrine Dysfunction
Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.
Time frame: 3- and 5- years post radiation treatment
Neurocognitive Effects
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.
Time frame: Baseline and Follow-up (median of 6 years)
Progression Free Survival
3- and 5-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.
Time frame: 3- and 5-years post radiation treatment
Treatment Efficiency
To modify the speed of treating patients requiring cranial spinal irradiation (CSI) and improve the safety of treating patients under anesthesia
Time frame: 2 years
Percentage of Participants Who Experienced an Acute Toxicity by Grade
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.
Time frame: 3 months after radiation therapy
| Milestone | Proton Beam Radiation |
|---|---|
| Started | 90 |
| Completed | 89 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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)
| percentage of participants | Proton Beam Radiation |
|---|---|
| 3-Years post RT (radiation treatment) | 26 (16 to 37) |
| 5-Years post RT | 27 (17 to 38) |
Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.
| percentage of participants | Proton Beam Radiation |
|---|---|
| 3-Years post RT | 46 (34 to 57) |
| 5-Years post RT | 67 (54 to 77) |
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.
| score on a scale | Proton Beam Radiation |
|---|---|
| Baseline FSIQ | 102.7 ± 12.5 |
| Follow-up FSIQ | 91.7 ± 20.5 |
3- and 5-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.
| percentage of participants | Proton Beam Radiation |
|---|---|
| 3-Year post RT | 83.2 (75.8 to 91.3) |
| 5-Year post RT | 79.6 (71.7 to 88.5) |
To modify the speed of treating patients requiring cranial spinal irradiation (CSI) and improve the safety of treating patients under anesthesia
No measurements were reported for this outcome.
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.
| Participants | Proton Beam Radiation |
|---|---|
| Grade 1 | 90 |
| Grade 2 | 84 |
| Grade 3 | 36 |
| Grade 4 | 12 |
| Grade 5 | 0 |
Collected over Through start of radiotherapy treatment to study end (up to 5 years post radiation treatment). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proton Beam Radiation | 19/90 (21.1%) | 9/90 (10%) | 89/90 (98.9%) |
| Event | Proton Beam Radiation |
|---|---|
| Neutrophil count decreasedInvestigations | 4/90 |
| AnorexiaMetabolism and nutrition disorders | 4/90 |
| AlopeciaSkin and subcutaneous tissue disorders | 3/90 |
| AnemiaBlood and lymphatic system disorders | 3/90 |
| Dry eyeEye disorders | 2/90 |
| Dermatitis radiationInjury, poisoning and procedural complications | 2/90 |
| Middle ear inflammationEar and labyrinth disorders | 1/90 |
| EsophagitisGastrointestinal disorders | 1/90 |
| VomitingGastrointestinal disorders | 1/90 |
| Eye infectionInfections and infestations | 1/90 |
| Event | Proton Beam Radiation |
|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 81/90 |
| Dermatitis radiationInjury, poisoning and procedural complications | 79/90 |
| FatigueGeneral disorders | 72/90 |
| NauseaGastrointestinal disorders | 60/90 |
| AnorexiaMetabolism and nutrition disorders | 56/90 |
| VomitingGastrointestinal disorders | 51/90 |
| Hearing impairedEar and labyrinth disorders | 48/90 |
| HeadacheNervous system disorders | 40/90 |
| Cognitive disturbanceNervous system disorders | 34/90 |
| Weight lossInvestigations | 32/90 |
| Age, Continuous(years) | Proton Beam Radiation |
|---|---|
| Median | 8.3 (6.4 to 12.5) |
| Sex: Female, Male(Participants) | Proton Beam Radiation |
|---|---|
| Female | 36 |
| Male | 54 |
| Race (NIH/OMB)(Participants) | Proton Beam Radiation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 79 |
| More than one race | 3 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | Proton Beam Radiation |
|---|---|
| United States | 90 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2010 to primary completion in Nov 2021, 139 months.
Results were first posted in Aug 2025, 3 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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