Pediatric Patients Treated With Radiation TherapyNCT01696721
Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
An observational study of Pediatric Patients Treated With Radiation Therapy, run by Massachusetts General Hospital at 26 sites in 3 countries.
Trial summary
In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Patients Treated With Radiation Therapy
- How many people
- 5,000 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Jul 2012to Dec 2028
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients age <22 treated with radiation therapy
Eligibility Criteria:
- Patients treated with radiation therapy at one of the participating centers
- Age < 22 at time of treatment start.
- Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
- Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
- Patients may be enrolled on the PPCR concurrently with another study or clinical trial.
Trial locations and contacts
26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 3 countries
United States24 sites, 23 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Bree Eaton, MD, brupper@emory.edu
Bree Eaton, MD
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Young Kwok, MD, ykwok@umm.edu
Young Kwok, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Torunn I Yock, MD, 6177266876, tyock@partners.org
Torunn I Yock, MD
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
Dana Casey, MD, dana_casey@med.unc.edu
Dana Casey, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Joshua Palmer, MD, Joshua.Palmer@osumc.edu
Joshua Palmer, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Arnold Paulino, MD, APaulino@mdanderson.org
Arnold Paulino, MD
- Recruiting
Texas Center for Proton Therapy
Irving, Texas, 75063
Victor Mangona, MD, Victor.Mangona@usoncology.com
Victor Mangona, MD
- Recruiting
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206
Daniel Indelicato, MD, dindelicato@floridaproton.org
Daniel Indelicato, MD
- Active, not recruiting
Provision Center for Proton Therapy
Knoxville, Tennessee, 37909
- Recruiting
Cincinnati Children's Proton Therapy Center
Liberty Township, Ohio, 45044
John Perentesis, MD, John.Perentesis@cchmc.org
John Perentesis, MD
- Recruiting
New York Proton Center
New York, New York, 10035
Suzanne Wolden, MD, woldens@MSKCC.ORG
Suzanne Wolden, MD
- Recruiting
Oklahoma Proton Center
Oklahoma City, Oklahoma, 73142
John H Chang, MD, John.Chang@OKCProton.com
John H Chang, MD
- Recruiting
ProCure Proton Therapy Center- Oklahoma
Oklahoma City, Oklahoma, 73142
Jae Y Lee, MD, PhD, Jae.lee@procure.com
Jae Y Lee, MD, PhD
- Recruiting
Stanford University
Palo Alto, California, 94304
Susan Hiniker, MD, shiniker@stanford.edu
Susan Hiniker, MD
- Recruiting
University of Pennsylvania - Roberts Proton Therapy Center
Philadelphia, Pennsylvania, 19104
Christine Hill-Kayser, MD, hill@uphs.upenn.edu
Christine Hill-Kayser, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Nadia Laack, MD, Laack.nadia@mayo.edu
Nadia Laack, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Matthew Poppe, MD, Matthew.Poppe@hci.utah.edu
Matthew Poppe, MD
- Recruiting
California Protons Cancer Therapy Center
San Diego, California, 92121
Iain MacEwan, MD, iain.macewan@californiaprotons.com
Iain MacEwan, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Steve Braunstein, MD, Steve.Braunstein@ucsf.edu
Steve Braunstein, MD
- Recruiting
University of Washington- Seattle Cancer Care Alliance
Seattle, Washington, 98109
Ralph Ermoian, MD, ralphpe@uw.edu
Ralph Ermoian, MD
- Recruiting
ProCure Proton Therapy Center- New Jersey
Somerset, New Jersey, 08873
Josephine Blume, Josephine.blume@nj.procure.com
Suzanne Wolden, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Stephanie Perkins, MD, sperkins@wustl.edu
Stephanie Perkins, MD
- Recruiting
State University of New York Upstate Medical Center
Syracuse, New York, 13210
Paul Aridgides, MD, AridgidP@upstate.edu
Paul Aridgides, MD
- Recruiting
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
Stephen Mihalcik, MD, stephen.mihalcik@nm.org
Stephen Mihalcik, MD
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Hien Le, A/Prof, Hien.Le@sa.gov.au
Hien Le, A/Prof
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Princess Margaret Hospital
Toronto, Ontario, M5G 2C1
Derek Tsang, MD, derek.tsang@uhn.ca
Derek Tsang, MD
About this study
In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there is limited published data demonstrating these results. The goal of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with radiation in order to describe the population that currently receives radiation and better compare the short-term and long-term benefits of different types of radiotherapy. The data collected from this study will help facilitate research on radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver radiation therapy already collect in routine operations.
Read the detailed description
Once you are enrolled in the study, you will receive treatment, evaluations and follow up care for your type of cancer as determined by your treating physician according to clinical judgment and standard of care for your clinic. All treatments that you receive will be recorded, including all surgeries and chemotherapy given before or after PBRT. Treatment outcomes, like how you respond to treatment, side effects, and progression of your cancer will be collected as the information becomes available. A study coordinator or research nurse at your clinic will perform a chart review annually to update your status in the database. The study doctor will request any new data within the past year from you or your doctor.
We will be collecting the following data for the Registry:
At Screening: The following data will be collected from the time of diagnosis and initial staging:
- Patient demographics, date of birth, gender, race, zip code and insurance status
- Date of diagnosis
- Histologic or clinical diagnosis and staging relevant to diagnosis
- Imaging studies obtained and tumor measurements
- Lab evaluations which include routine blood tests, hormone levels, and any relevant lab results needed to assess you and baseline and follow-up visits
- Referring physician contact information
Treatment Data Collection: The following data regarding treatment will be collected:
- Treatments received before radiation therapy, including surgery, chemotherapy, dates and numbers of cycles, results of chemotherapy if available
- Dates and doses of radiation treatment
- Side effects observed
- Any treatments you received at the same time as proton radiation therapy
Follow-up Data Collection: The following data will be collected either as it comes in or annually following completion of your radiation therapy treatment:
- Disease and survival status
- Hospitalization, surgeries or other procedures
- New diagnoses of medical conditions
- Any lab results, including x-rays
- Medications you are taking
- Late side effects such as hearing loss, hormonal issues, any cardiac issues
- Development of any new types of cancers
- Dates of treatment after radiation therapy
- If you discontinued radiation therapy
- Laboratory/physician/dental or psychological evaluations
- Use of special services in school (IEP, FM hearing system, one on one tutor, special education) We would like to keep track of your medical condition for the rest of your life. We would like to do this by contacting you or your doctor once a year to see how you are doing. Keeping in touch with you and checking on your condition helps determine the long-term outcomes of individuals treated with proton beam radiation therapy.
In addition to research personnel at MGH, there are others that may have access to the data collected. This includes:
- Other research doctors and medical centers participating in this research, if applicable
- Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research. For instance copies of your imaging studies and treatment plan will be stored at MIMcloud. MIMcloud is a service offered through MIM Software Inc, a privately held company, that provides diagnostic imaging data management services.
- Being tested
- No intervention
- Keywords
- Proton Therapy, Pediatrics, Radiation Oncology, Photon Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients Treated with Protons | Proton Radiation Therapy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Registry
Establish a registry of pediatric patients treated with proton radiation therapy in the United States
Measured: 2 years
Secondary outcomes (4)
Describe patterns of care
Describe the patterns of care for pediatric patients receiving proton radiation therapy
Measured: 2 years
Describe patterns of follow-up
Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence
Measured: 2 years
Describe acute and late effects
Describe the acute and late effects in the children treated with proton radiotherapy
Measured: 2 years
Establish a cohort of photon-treated patients
Establish a control group of patients treated with photon radiotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Patients Treated With Radiation TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torunn Yock, MD, Massachusetts General Hospital
- Investigators
- Torunn I Yock, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696721
- Sponsor's protocol ID
- 12-103
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2012
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Krisch JM, Ermoian RP, Indelicato DJ, Lee JY, Perentesis JP, Perkins SM, Laack NN 2nd, Chang JH, MacEwan IJ, Wolden SL, Wang D, Yock TI, Aridgides PD. Outcomes following radiation therapy for embryonal tumor with multilayered rosettes (ETMR): results from the Pediatric Proton/Photon Consortium Registry (PPCR). J Neurooncol. 2025 Sep;174(2):369-380. doi: 10.1007/s11060-025-05065-2. Epub 2025 May 13.
PubMed 40358803
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
- ClinicalTrials.gov ID
- NCT01696721
- Acronym / sponsor ID
- 12-103
- Keywords
- Proton Therapy, Pediatrics, Radiation Oncology, Photon Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Oct 2012 (estimated)
- 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.
In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there is limited published data demonstrating these results. The goal of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with radiation in order to describe the population that currently receives radiation and better compare the short-term and long-term benefits of different types of radiotherapy. The data collected from this study will help facilitate research on radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver radiation therapy already collect in routine operations.
Detailed description
Once you are enrolled in the study, you will receive treatment, evaluations and follow up care for your type of cancer as determined by your treating physician according to clinical judgment and standard of care for your clinic. All treatments that you receive will be recorded, including all surgeries and chemotherapy given before or after PBRT. Treatment outcomes, like how you respond to treatment, side effects, and progression of your cancer will be collected as the information becomes available. A study coordinator or research nurse at your clinic will perform a chart review annually to update your status in the database. The study doctor will request any new data within the past year from you or your doctor.
We will be collecting the following data for the Registry:
At Screening: The following data will be collected from the time of diagnosis and initial staging:
- Patient demographics, date of birth, gender, race, zip code and insurance status
- Date of diagnosis
- Histologic or clinical diagnosis and staging relevant to diagnosis
- Imaging studies obtained and tumor measurements
- Lab evaluations which include routine blood tests, hormone levels, and any relevant lab results needed to assess you and baseline and follow-up visits
- Referring physician contact information
Treatment Data Collection: The following data regarding treatment will be collected:
- Treatments received before radiation therapy, including surgery, chemotherapy, dates and numbers of cycles, results of chemotherapy if available
- Dates and doses of radiation treatment
- Side effects observed
- Any treatments you received at the same time as proton radiation therapy
Follow-up Data Collection: The following data will be collected either as it comes in or annually following completion of your radiation therapy treatment:
- Disease and survival status
- Hospitalization, surgeries or other procedures
- New diagnoses of medical conditions
- Any lab results, including x-rays
- Medications you are taking
- Late side effects such as hearing loss, hormonal issues, any cardiac issues
- Development of any new types of cancers
- Dates of treatment after radiation therapy
- If you discontinued radiation therapy
- Laboratory/physician/dental or psychological evaluations
- Use of special services in school (IEP, FM hearing system, one on one tutor, special education) We would like to keep track of your medical condition for the rest of your life. We would like to do this by contacting you or your doctor once a year to see how you are doing. Keeping in touch with you and checking on your condition helps determine the long-term outcomes of individuals treated with proton beam radiation therapy.
In addition to research personnel at MGH, there are others that may have access to the data collected. This includes:
- Other research doctors and medical centers participating in this research, if applicable
- Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research. For instance copies of your imaging studies and treatment plan will be stored at MIMcloud. MIMcloud is a service offered through MIM Software Inc, a privately held company, that provides diagnostic imaging data management services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients Treated with Protons | – | Other: No interventionProton Radiation Therapy |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients age <22 treated with radiation therapy
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 |
|---|---|---|
| No intervention | Other | Pediatric Patients Treated with Protons |
Primary outcome
Establish Registry
Time frame: 2 years
Establish a registry of pediatric patients treated with proton radiation therapy in the United States
4 secondary outcomes
Describe patterns of care
Time frame: 2 years
Describe patterns of follow-up
Time frame: 2 years
Describe acute and late effects
Time frame: 2 years
Establish a cohort of photon-treated patients
Time frame: 2 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 5 Oct 2026.
- Derived from this study: PubMed 40358803Krisch JM, Ermoian RP, Indelicato DJ, Lee JY, Perentesis JP, Perkins SM, Laack NN 2nd, Chang JH, MacEwan IJ, Wolden SL, Wang D, Yock TI, Aridgides PD. Outcomes following radiation therapy for embryonal tumor with multilayered rosettes (ETMR): results from the Pediatric Proton/Photon Consortium Registry (PPCR). J Neurooncol. 2025 Sep;174(2):369-380. doi: 10.1007/s11060-025-05065-2. Epub 2025 May 13.
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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.
Torunn I Yock, MD principal investigator
Massachusetts General Hospital
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Patients Treated With Radiation Therapy, run by Massachusetts General Hospital at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, Canada. 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?
Contact Torunn I Yock, MD (6177266876, tyock@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish Registry (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696721, which also lists 1 linked publication.
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 5 Oct 2026.