Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01502150
First received: December 21, 2011
Last updated: September 5, 2014
Last verified: September 2014

December 21, 2011
September 5, 2014
June 2005
June 2020   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01502150 on ClinicalTrials.gov Archive Site
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Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
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.

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 800 patients will be enrolled at MD Anderson.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pediatric cancer patients receiving proton radiation therapy at MD Anderson Cancer Center in Houston, Texas

Pediatric Cancer
  • 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.
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.
Interventions:
  • Other: Data Collection
  • Other: Dose Distribution Data Collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
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June 2020   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact: Anita Mahajan, MD 713-563-2359
United States
 
NCT01502150
PCR05-0208
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Anita Mahajan, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP