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
  Purpose

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.


Condition Intervention
Pediatric Cancer
Other: Data Collection
Other: Dose Distribution Data Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 800
Study Start Date: June 2005
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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 800 patients will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502150

Contacts
Contact: Anita Mahajan, MD 713-563-2359

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anita Mahajan, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
u  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01502150     History of Changes
Other Study ID Numbers: PCR05-0208
Study First Received: December 21, 2011
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Pediatric Cancer
Proton Radiation Therapy
Proton beam radiotherapy
PBT
Data Collection
Database
Acute and late normal tissue toxicities
Dosimetric data
Toxicity data

ClinicalTrials.gov processed this record on September 18, 2014