Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy

• ClinicalTrials.gov Identifier: NCT01696721
• Recruitment Status: Recruiting
• First Posted: October 1, 2012
• Last Update Posted: January 9, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Torunn Yock, MD, Massachusetts General Hospital

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Pediatric Patients Treated With Radiation Therapy	Other: No intervention

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

• Study Type: Observational
• Estimated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
• Actual Study Start Date: July 2012
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pediatric Patients Treated with Protons; Proton Radiation Therapy	Other: No intervention

Outcome Measures

Primary Outcome Measures :

1. Establish Registry [ Time Frame: 2 years ]
   Establish a registry of pediatric patients treated with proton radiation therapy in the United States

Secondary Outcome Measures :

1. Describe patterns of care [ Time Frame: 2 years ]
   Describe the patterns of care for pediatric patients receiving proton radiation therapy
2. Describe patterns of follow-up [ Time Frame: 2 years ]
   Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence
3. Describe acute and late effects [ Time Frame: 2 years ]
   Describe the acute and late effects in the children treated with proton radiotherapy
4. Establish a cohort of photon-treated patients [ Time Frame: 2 years ]
   Establish a control group of patients treated with photon radiotherapy

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients age <22 treated with radiation therapy

Criteria

Eligibility Criteria:

1. Patients treated with radiation therapy at one of the participating centers
2. Age < 22 at time of treatment start.
3. Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
4. Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
5. Patients may be enrolled on the PPCR concurrently with another study or clinical trial.

Contacts and Locations

Contacts

Contact: Torunn I Yock, MD; 6177266876; tyock@partners.org

Locations

United States, Florida

University of Florida Health Proton Therapy Institute; Recruiting

Jacksonville, Florida, United States, 32206

Contact: Jackie Causer JCauser@floridaproton.org

Principal Investigator: Daniel Indelicato, M.D.

United States, Illinois

Northwestern Medicine Chicago Proton Center; Recruiting

Warrenville, Illinois, United States, 60555

Contact: Karen Brown 630-821-6400 Karen.Brown@nm.org

Principal Investigator: William Hartsell, M.D.

United States, Maryland

Maryland Proton Treatment Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Jill Harper jillharper@umm.edu

Principal Investigator: Young Kwok, MD

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Torunn I Yock, MD 617-726-6876 tyock@partners.org

Principal Investigator: Torunn I Yock, MD

United States, Minnesota

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Nadia Laack, MD Laack.nadia@mayo.edu

Principal Investigator: Nadia Laack, MD

United States, Missouri

Washington University; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Stephanie Perkins, M.D. sperkins@radonc.wustl.edu

Principal Investigator: Stephanie Perkins, M.D.

United States, New Jersey

ProCure Proton Therapy Center- New Jersey; Recruiting

Somerset, New Jersey, United States, 08873

Contact: Josephine Blume Josephine.blume@nj.procure.com

Principal Investigator: Suzanne Wolden, MD

United States, Ohio

Cincinnati Children's Proton Therapy Center; Recruiting

Liberty Township, Ohio, United States, 45044

Contact: Laura Fossett Laura.Fossett@cchmc.org

Principal Investigator: John Perentesis, MD

United States, Oklahoma

ProCure Proton Therapy Center- Oklahoma; Recruiting

Oklahoma City, Oklahoma, United States, 73142

Contact: Michael Confer, MD mconfer@rma-ok.com

Principal Investigator: Michael Confer, MD

United States, Pennsylvania

University of Pennsylvania - Roberts Proton Therapy Center; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Christine Hill-Kayser, M.D. hill@uphs.upenn.edu

Principal Investigator: Christine Hill-Kayser, M.D.

United States, Tennessee

Provision CARES Proton Therapy Center; Recruiting

Knoxville, Tennessee, United States, 37909

Contact: Natalie Freeman natalie.freeman@biomed-research.com

Principal Investigator: J. Ben Wilkinson, MD

United States, Texas

MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: Nancy Philip nkumbalasseriyil@mdanderson.org

Principal Investigator: Arnold Paulino, MD

Texas Center for Proton Therapy; Recruiting

Irving, Texas, United States, 75063

Contact: Victor Mangona, MD Victor.Mangona@usoncology.com

Principal Investigator: Victor Mangona, MD

United States, Washington

University of Washington- Seattle Cancer Care Alliance; Recruiting

Seattle, Washington, United States, 98109

Contact: Latha Parvathaneni lathap@uw.edu

Principal Investigator: Ralph Ermoian, MD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Torunn I Yock, MD; Massachusetts General Hospital

More Information

• Responsible Party: Torunn Yock, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01696721
• Other Study ID Numbers: 12-103
• First Posted: October 1, 2012
• Last Update Posted: January 9, 2023
• Last Verified: January 2023

Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:

Proton Therapy; Pediatrics; Radiation Oncology; Photon Therapy