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.
Other: Data Collection
Other: Dose Distribution Data Collection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics|
- Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy [ Time Frame: 15 years ] [ Designated as safety issue: No ]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).
|Study Start Date:||June 2005|
|Estimated Primary Completion Date:||June 2020 (Final data collection date for primary outcome measure)|
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.
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 M. D. Anderson researchers will request that the results be sent to them at M. D. Anderson.
In the future, it is possible that some of your information, including digital CT and/or MRI images, may be used by Varian Medical Systems to create an anatomic library that will be used to help diagnose and plan treatment for future patients.
Before your information and/or images are sent to Varian Medical Systems, the information and images will be deidentified to protect your privacy. No identifying information will be directly linked to your information or images. Only the researcher in charge of this study will have access to the code numbers and be able to link the information or images back to you. Varian Medical Systems will never have the ability to link any of the information or images to your identity. MD Anderson will not have oversight of any of your information and/or images that are sent to Varian Medical Systems.
This is an investigational study. Proton radiotherapy is FDA approved. Researchers hope to enroll all children who will be treated with proton radiotherapy at M. D. Anderson on this study so that as much information as possible will be gathered. Up to 750 patients will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502150
|Contact: Anita Mahajan, MD||713-563-2359|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anita Mahajan, MD||UT MD Anderson Cancer Center|