Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck (CN01)

June 9, 2022 updated by: University of Florida

A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck

The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

Study Overview

Status

Completed

Conditions

Detailed Description

Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated at a radiation oncology clinic

Description

Inclusion Criteria:

  • Estimated >5 cc of the brain tissue to receive >5 CGE radiation
  • Patient must be less than 21 years of age at time of consent.
  • Patients that require localized and craniospinal irradiation.
  • Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group.

Exclusion Criteria:

  • Prior radiation therapy.
  • Evidence of metastases outside the central nervous system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation and quality of life
Central Nervous System Tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure late effects of proton therapy on pediatric patients with CNS tumors
Time Frame: 5.4 years after treatment completion
5.4 years after treatment completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.
Time Frame: 12 years after treatment completion
12 years after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Daniel J. Indelicato, MD, University of Florida Proton Therapy Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 21, 2022

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201701741
  • UFPTI 0903-CN01 (Other Identifier: University of Florida Project #)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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