PPCR: Registry for Pedi Patients Treated With Proton RT

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01696721
First received: September 27, 2012
Last updated: April 11, 2014
Last verified: April 2014
  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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Establish Registry [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Describe the patterns of care for pediatric patients receiving proton radiation therapy

  • Describe patterns of follow-up [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Describe the acute and late effects in the children treated with proton radiotherapy


Estimated Enrollment: 5000
Study Start Date: July 2012
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Daniel Indelicato, M.D.       dindelicato@floridaproton.org   
Principal Investigator: Daniel Indelicato, M.D.         
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: William Hartsell, M.D.    630-821-6400      
Principal Investigator: William Hartsell, M.D.         
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, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Stephanie Perkins, M.D.       sperkins@radonc.wustl.edu   
Principal Investigator: Stephanie Perkins, M.D.         
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.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Torunn Yock, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01696721     History of Changes
Other Study ID Numbers: 12-103
Study First Received: September 27, 2012
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Proton Therapy
Pediatrics
Radiation Oncology

ClinicalTrials.gov processed this record on September 29, 2014