Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

The goal of this research study is to collect information on the side effects of proton therapy and the details of proton treatment plans so that researchers can develop a method to predict the risk of side effects and to improve the planning and delivery of proton treatment for patients in the future.

Study Overview

• Status: Unknown
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: Data Collection; Other: Dose Distribution Data Collection

Detailed Description

If you agree to take part in this study, researchers will gather information about your treatment and treatment outcomes and store it electronically in a database. By carefully evaluating the data about your treatment, researchers may improve proton treatment for patients in the future. There will be no change to your recommended standard of care and follow-up studies. The treatment information and follow-up information will be stored in a database. The information will then be available at a later date for researchers to study. The database will be stored on a secure information network, and only those people who are involved with this research and who have prior approval from the study doctor will have access to it.

Researchers will request information from the follow-up visits that you have as part of your standard of care yearly or more often and test results for at least 10-15 years. The tests may be performed at other clinics, but MD Anderson researchers will request that the results be sent to them at MD Anderson.

This is an investigational study. Proton radiotherapy is FDA approved. Researchers hope to enroll all children who will be treated with proton radiotherapy at MD Anderson on this study so that as much information as possible will be gathered. Up to 1000 patients will be enrolled at MD Anderson.

• Study Type: Observational
• Enrollment (Actual): 798

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric cancer patients receiving proton radiation therapy at MD Anderson Cancer Center in Houston, Texas

Description

Inclusion Criteria

1. All patients under the age of 18 who are treated with PBT will be eligible to participate in this trial.
2. Signed informed consent must be obtained from the patient or patient's representative prior to study enrollment.

Exclusion Criteria:

1. Pregnant females are not eligible.
2. Patient or patient's parent or legal guardian representative is unable or unwilling to give informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pediatric Proton Therapy Patients; Data collection of MDACC patients under the age of 18 treated with proton radiotherapy. Proton dosimetry data collection, corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.

Other: Data Collection; Information collected from follow-up visits post proton radiation therapy yearly or more often, and test results for at least 10-15 years.; Other: Dose Distribution Data Collection; Data collection of complete plan information, including dose distribution, beam configuration and images, computed tomography (CT) images acquired on multiple days and 4D CT's for respiratory correlated imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy	For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade >= 2 late toxicity).	15 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Arnold dela Cruz Paulino, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2005
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (ESTIMATE): December 30, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Pediatric Cancer; Database; Data Collection; Proton Radiation Therapy; PBT; Proton beam radiotherapy; Acute and late normal tissue toxicities; Dosimetric data; Toxicity data
• Other Study ID Numbers: PCR05-0208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No