Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01502150|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2011
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment|
|Pediatric Cancer||Other: Data Collection Other: Dose Distribution Data Collection|
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|
|Actual Enrollment :||798 participants|
|Official Title:||Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics|
|Actual Study Start Date :||June 16, 2005|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
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.
- Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502150
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Arnold dela Cruz Paulino, MD||M.D. Anderson Cancer Center|