Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

NCT01502150 | Unknown

• 1 other identifier: PCR05-0208
• Study Type: observational
• Target: 798
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Other: Dose Distribution Data Collection

Interventions

Data Collection OTHER

Information collected from follow-up visits post proton radiation therapy yearly or more often, and test results for at least 10-15 years.

Pediatric Proton Therapy Patients

Dose Distribution Data Collection OTHER

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients under the age of 18 who are treated with PBT will be eligible to participate in this trial.
• Signed informed consent must be obtained from the patient or patient's representative prior to study enrollment.

You may not qualify if:

• Pregnant females are not eligible.
• Patient or patient's parent or legal guardian representative is unable or unwilling to give informed consent.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Arnold dela Cruz Paulino, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 30, 2011
• Study Start: June 16, 2005
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

US (1)