Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01696721
Previous Study | Return to List | Next Study

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

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.
ClinicalTrials.gov Identifier: NCT01696721
Recruitment Status : Recruiting
First Posted : October 1, 2012
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital

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

  Show Detailed Description

Layout table for study information
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
Study Start Date : July 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

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



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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
Layout table for location contacts
Contact: Torunn I Yock, MD 6177266876 tyock@partners.org

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital

Layout table for additonal 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 Posted: October 1, 2012    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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