Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
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.
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.
Observational Model: Cohort, Time Perspective: Prospective
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).
Anita Mahajan, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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