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Trial record 1 of 1 for:    NCT01502150
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Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01502150
Recruitment Status : Active, not recruiting
First Posted : December 30, 2011
Last Update Posted : May 10, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Pediatric Cancer Other: Data Collection Other: Dose Distribution Data Collection

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.

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Study Type : Observational
Actual Enrollment : 798 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics
Actual Study Start Date : June 16, 2005
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy [ Time Frame: 15 years ]
    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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01502150

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Arnold dela Cruz Paulino, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01502150    
Other Study ID Numbers: PCR05-0208
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Pediatric Cancer
Proton Radiation Therapy
Proton beam radiotherapy
Data Collection
Acute and late normal tissue toxicities
Dosimetric data
Toxicity data