Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

• Conditions: Pediatric Cancer
• Interventions: Other: Data Collection; Other: Dose Distribution Data Collection

• Registration Number: NCT01502150
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2005-06-16
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10
• Primary Completion: 2020-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 798

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Proton Therapy Patients	Data Collection	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.
Pediatric Proton Therapy Patients	Dose Distribution Data Collection	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.

Primary Outcome Measures

Name	Time	Method
Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy	15 years	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).

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States