Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

Pediatric Cancer Clinical Trial

Official title:

Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01502150
• Other study ID #: PCR05-0208
• Status: Active, not recruiting
• Start date: June 16, 2005
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 798
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection From Pediatric Patients Undergoing Proton Radiation Therapy	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).	15 years

External Links

•   University of Texas MD Anderson Cancer Center Website