Brain TumorNCT03281889
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
A study testing Proton Beam in people with Brain Tumor, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Proton Beam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 3 years and ≤ 18 years at the time of registration
- Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
- Life expectancy ≥ 12 months.
- Signed informed consent document and assent when appropriate.
- HGB of > 10 g/L and PLT count > 80 K/uL
Who cannot join
- Any prior therapeutic radiation therapy > 500 cGy has been delivered.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
- Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements.
- Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
- Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02214
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.
The radiation involved in this study is:
-Proton Radiation
Read the detailed description
This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.
The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.
In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
- Conditions
- Brain Tumor
- Being tested
- Proton Beam
- Keywords
- Brain Tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton BeamRadiation
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiotherapy | Experimental | * Patients will be treated with Proton Beam once daily 5 days per week.
* Doses will be prescribed such that maximum possible coverage is achieved Receives: Radiation: Proton Beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: 3 months
Secondary outcomes (10)
Early marrow changes in the vertebral bodies
Summary of early marrow changes in the vertebral bodies by Magnetic resonance imaging (MRI) of the spine during radiation therapy (RT) by comparing one study MRI to the baseline pre-RT MRI.
Measured: 2 years
Vertebral column growth (measured by MRI) over 1 year
Summary of vertebral column growth (measured by MRI) over 1 year following vertebral body sparing cranio-spinal irradiation in pediatric patients.
Measured: Last day of treatment to 1 year later
Change in sitting height and standing height
Summary of the changes in the participants sitting and standing heights.
Measured: Annually for 5 years
Time to abnormality in spinal curvature
Participants are monitored both clinically and by MRI for any abnormality in spinal curvature. The time to abnormality in spine curvature will be measured from the start of radiation to the date of documented abnormality or censored at the date of last follow-up for patients still alive with normal spine.
Measured: 5 years
Disease Free Survival
Disease-free survival is measured from the start of radiation to the date of progressive disease based on imaging studies obtained as standard care or to the date of death due to any cause, whichever is earlier. Disease-free survival will be estimated using the Kaplan-Meier method. Patients without progressive disease and still alive will be censored at their date of last contact.
Measured: 5 years
Pattern of Disease Relapse
Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
Measured: 2 years
Complete blood counts (CBC) over time
Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.
Measured: Annually for 5 years
Change in levels of vitamin D, calcium, and growth hormones over time
Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
Measured: Annually for 5 years
Weight
Summary of the changes in weight of the participants as assessed by yearly evaluations.
Measured: Annually for 5 years
BMI
Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Measured: Annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start4 Jan 2018
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kevin X. Liu, MD, DPHIL, Massachusetts General Hospital
- Investigators
- Shannon MacDonald, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281889
- Sponsor's protocol ID
- 17-283
- Other IDs
- U19CA021239-37
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2017
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
- ClinicalTrials.gov ID
- NCT03281889
- Acronym / sponsor ID
- 17-283
- Conditions
- Brain Tumor
- Keywords
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.
The radiation involved in this study is:
-Proton Radiation
Detailed description
This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.
The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.
In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Radiotherapy | Experimental | Radiation: Proton Beam* Patients will be treated with Proton Beam once daily 5 days per week. * Doses will be prescribed such that maximum possible coverage is achieved |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age ≥ 3 years and ≤ 18 years at the time of registration
- Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
- Life expectancy ≥ 12 months.
- Signed informed consent document and assent when appropriate.
- HGB of > 10 g/L and PLT count > 80 K/uL
Key exclusion criteria (5 listed)
- Any prior therapeutic radiation therapy > 500 cGy has been delivered.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
- Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements.
- Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
- Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beamprecision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue | Radiation | Proton Radiotherapy |
Primary outcome
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
Time frame: 3 months
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
10 secondary outcomes
Early marrow changes in the vertebral bodies
Time frame: 2 years
Vertebral column growth (measured by MRI) over 1 year
Time frame: Last day of treatment to 1 year later
Change in sitting height and standing height
Time frame: Annually for 5 years
Time to abnormality in spinal curvature
Time frame: 5 years
Disease Free Survival
Time frame: 5 years
Pattern of Disease Relapse
Time frame: 2 years
Complete blood counts (CBC) over time
Time frame: Annually for 5 years
Change in levels of vitamin D, calcium, and growth hormones over time
Time frame: Annually for 5 years
Weight
Time frame: Annually for 5 years
BMI
Time frame: Annually for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon MacDonald, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam in people with Brain Tumor, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.