Additional objectives of the PPCR registry are to:

Pediatric Proton Consortium Registry Logo
  1. Describe who is getting referred for proton radiotherapy in the United States
  2. Identify the patients for whom proton therapy is most beneficial offering a significant advantage over photon based radiotherapy
  3. Provide a platform for comparative research through  Children's Oncology Group (COG) and other consortia or databases
  4. Monitor how well we as health care providers are meeting our overall oncologic goals of attaining high rates of cure while minimizing the adverse late effects of treatment in our childhood cancer survivors

Background

Radiotherapy is often integral to attaining a cure in pediatric cancer patients. However, it can have adverse side effects that manifest over time as we irradiate in a dose- and age-dependent manner. Radiation is known to inhibit the growth and development of tissue, irrespective of healthy or cancerous tissue. Curable brain tumors are the most common solid tumor in pediatric population and often require radiotherapy to cure them. However, brain radiotherapy can affect neurocognitive development, hearing and neuroendocrine function, as well as have adverse psychosocial effects. Solid tumors located outside the brain that often require radiotherapy for cure include: sarcomas, neuroblastomas, and numerous varieties of other tumors. Radiotherapy to these other parts of the body can have adverse functional and cosmetic consequences. Radiation therapy is a carcinogen, and, while effective at curing a tumor, places a child at increased risk for a radiation-induced tumor many years later. In combination, these adverse health effects can impact a childhood cancer survivors’ quality of life, and even shorten their lifespan.

Graph of Pediatric Proton Consortium Registry primary diagnosis

 

Graph of Pediatric Proton Consortium Registry Non-CNS Histologies

 

Graph of Pediatric Proton Consortium Registry CNS Histologies

Rationale for Proton Radiation

Proton radiotherapy, although not technically a “new” treatment, is a modality that only recently is becoming a readily available treatment option in the United States. Proton radiotherapy has unique physical characteristics that provide a significant advantage over even the most technically sophisticated photon based radiotherapy. Proton radiotherapy is a form of radiation that better places dose into the desired target, while minimizing dose to surrounding normal tissue by a factor of two to three over photon therapy. Since the adverse side effects of radiation therapy are directly correlated with dose to normal tissues, the use of protons should reduce the prevalence and severity of late adverse side effects, a significant advantage in treating pediatric patients. There is ample dosimetric data supporting this hypothesis, but clinical data is scant. Due to the heterogeneity and relative rarity of pediatric cancers, amassing clinical data takes a significant amount of time, and any single institution would be hampered by limited patient numbers. Thus the success of this registry is founded on the collaborative efforts of each participating institution to provided data and together, benefit from our joint contributions.

Institutional Registry Participants

Accrual as of March 15, 2017: 1,629 patients

MassGeneral Hospital for Children logo

Massachusetts General Hospital- Lead Institution
Overall and Site PI: Torunn I. Yock, MD, MCH
Date Approved for Enrollment: 10/2012


Northwestern Medicine Chicago Proton Center logo

Northwestern Medicine Chicago Proton Center
Site PI: William Hartsell, MD
Date Approved for Enrollment: 9/2013


University of Florida: Health Proton Therapy Institute logo

University of Florida: Health Proton Therapy Institute
Site PI: Daniel Indelicato, MD
Date Approved for Enrollment: 10/2013


Washington University: S. Lee Kling Proton Therapy Center logo

Washington University: S. Lee Kling Proton Therapy Center
Site PI: Stephanie Perkins, MD
Date Approved for Enrollment: 2/2014


MD Anderson Proton Therapy Center logo

MD Anderson Proton Therapy Center
Site PI: Arnold dela Cruz Paulino, MD
Date Approved for Enrollment: 5/2014


University of Pennsylvania: Perelman Center for Advanced Medicine logo

University of Pennsylvania: Perelman Center for Advanced Medicine
Site PI: Christine Hill-Kaiser, MD
Date Approved for Enrollment: 2/2014


University of Washington: Seattle Cancer Care Alliance logo

University of Washington: Seattle Cancer Care Alliance
Site PI: Ralph Ermoian, MD
Date Approved for Enrollment: 2/2016


ProCure Proton Therapy Center- New Jersey logo

ProCure Proton Therapy Center- New Jersey
Site PI: Oren Cahlon, MD
Date Approved for Enrollment: 6/2016


ProCure Proton Therapy Center- New Jersey logo

ProCure Proton Therapy Center-Oklahoma City
Site PI: Andrew L. Chang, MD
Date Approved for Enrollment: 6/2016


Mayo Clinic Rochester: Proton Beam Therapy Program logo

Mayo Clinic Rochester: Proton Beam Therapy Program
Site PI: Nadia Laack, MD
Date Approved for Enrollment: 9/2016


Texas Center for Proton Therapy logo

Texas Center for Proton Therapy
Site PI: Victor Mangona, MD
Date Approved for Enrollment: 11/2016


Maryland Proton Treatment Center logo

Maryland Proton Treatment Center
Site PI: Young Kwok, MD
Date Approved for Enrollment: 2/2017


 

Graph of Pediatric Proton Consortium Registry cumulative accrual by site

 

Graph of Pediatric Proton Consortium Registry cumulative accrual by site

 

Graph of Pediatric Proton Consortium Registry cumulative accrual across all sites

Institutions Pending Activation:

Cincinnati Children’s Hospital Proton Center
      Site PI: John Perentesis, MD
University of Oklahoma: Stephenson Cancer Center
      Site PI: Ozer Algan , MD

Registry Description

All pediatric patients (defined as <22 years old) receiving proton radiation at participating centers are eligible to be enrolled in the study. Data is captured via REDCap, a secure, web- based data collection platform with online survey capabilities. Currently, there are over 2,000 potential data fields collecting information on demographics, diagnosis, baseline treatment and health details, as well as follow up health information. The database is constructed using branching logic, such that only fields relevant to the previous answers are presented, and subsequent questions populate based on data input. Additionally, Patient Reported Outcome Measures (PROMs) are currently being incorporated. The PedsQL Quality of Life (QoL) survey has been administered through the PPCR at Massachusetts General Hospital and is being rolled out to our participating institutions to further bolster the database. Additionally, treatment planning CT and RT plans are submitted to QARC/IROC RI (with diagnostic imaging at baseline and follow up). http://www.qarc.org/

RedCap Logo

Pediatric Proton Consortium Registry  Figure 1

Registration

The PPCR is registered on www.clinicaltrials.gov with the identifier NCT01696721, Torunn Yock, MD Responsible Party.

Funding

The project was supported by the Federal Share of program income earned by Massachusetts General Hospital on C06 CA059267, Proton Therapy Research and Treatment Center.

Interested in supporting this work or the Pediatric Proton Center?

Contact Information

Natassya Bedos: Multi-Center Coordinator, Massachusetts General Hospital
nbedos@mgh.harvard.edu
Tel
: 617-643-6086

Sara Gallotto: Project Manager, Massachusetts General Hospital
sgallotto@mgh.harvard.edu
Tel: 617-643-9947
Torunn I Yock, MD MCH: Consortium Principal Investigator, Massachusetts General Hospitaltyock@mgh.harvard.edu

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