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Clinical Trials/NCT01067196
NCT01067196
Completed
Not Applicable

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

University of Florida1 site in 1 country500 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Nervous System Tumors
Sponsor
University of Florida
Enrollment
500
Locations
1
Primary Endpoint
Measure late effects of proton therapy on pediatric patients with CNS tumors
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
May 21, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Measure late effects of proton therapy on pediatric patients with CNS tumors

Time Frame: 5.4 years after treatment completion

Secondary Outcomes

  • Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.(12 years after treatment completion)

Study Sites (1)

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