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Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

18 Years
Open (Enrolling)
Pediatric Cancer

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Trial Information

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy

Outcome Description:

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).

Outcome Time Frame:

15 years

Safety Issue:


Principal Investigator

Anita Mahajan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Pediatric Cancer
  • Pediatric Cancer
  • Proton Radiation Therapy
  • Proton beam radiotherapy
  • PBT
  • Data Collection
  • Database
  • Acute and late normal tissue toxicities
  • Dosimetric data
  • Toxicity data



UT MD Anderson Cancer CenterHouston, Texas  77030