Clinical trial NCT01502150: Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
Official title: Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Cancer
Keywords: Pediatric Cancer
Proton Radiation Therapy
Proton beam radiotherapy
PBT
Data Collection
Database
Acute and late normal tissue toxicities
Dosimetric data
Toxicity data
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 798
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cancer patients receiving proton radiation therapy at MD Anderson Cancer Center in Houston, Texas

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Arnold dela Cruz Paulino, MD
role: PRINCIPAL_INVESTIGATOR
References: