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PPCR: Registry for Pedi Patients Treated With Proton RT

This study is currently recruiting participants.
Verified October 2017 by Torunn Yock, MD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696721
First Posted: October 1, 2012
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
  Purpose
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 Pediatric Proton Consortium Registry (PPCR) is to enroll children treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver proton radiation therapy already collect in routine operations.

Condition Intervention
Pediatric Patients Treated With Proton Beam Radiation Therapy Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Proton Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Proton Radiation Therapy

Further study details as provided by Torunn Yock, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Establish Registry [ Time Frame: 2 years ]
    Establish a registry of pediatric patients treated with proton radiation therapy in the United States


Secondary Outcome Measures:
  • Describe patterns of care [ Time Frame: 2 years ]
    Describe the patterns of care for pediatric patients receiving proton radiation therapy

  • 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

  • Describe acute and late effects [ Time Frame: 2 years ]
    Describe the acute and late effects in the children treated with proton radiotherapy


Estimated Enrollment: 5000
Study Start Date: July 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric Patients Treated with Protons
Proton Radiation Therapy
Other: No intervention

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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 proton beam radiation therapy
Criteria

Eligibility Criteria:

  1. Patients treated with proton 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696721


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

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Ashley Williams       awilliams@floridaproton.org   
Principal Investigator: Daniel Indelicato, M.D.         
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Shirley Samuel    630-821-6400    Shirley.samuel@cadencehealth.org   
Principal Investigator: William Hartsell, M.D.         
United States, Maryland
Maryland Proton Treatment Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Fahima Khan       fahimakhan@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: Oren Cahlon, MD         
United States, Oklahoma
ProCure Proton Therapy Center- Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Kayla Tarrant       Kayla.tarrant.@okc.procure.com   
Principal Investigator: Andrew Chang, 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, 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: Lashundra Coleman       Lashundra.coleman@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     History of Changes
Other Study ID Numbers: 12-103
First Submitted: September 27, 2012
First Posted: October 1, 2012
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
Proton Therapy
Pediatrics
Radiation Oncology