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

This study has been completed.
Information provided by (Responsible Party):
University of Florida Identifier:
First received: February 9, 2010
Last updated: December 16, 2015
Last verified: December 2015
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.

Central Nervous System Tumors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck

Resource links provided by NLM:

Further study details as provided by University of Florida:

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

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

Enrollment: 442
Study Start Date: February 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Observation and quality of life
Central Nervous System Tumors

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

Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated at a radiation oncology clinic

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01067196

United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Principal Investigator: Daniel J. Indelicato, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Responsible Party: University of Florida Identifier: NCT01067196     History of Changes
Other Study ID Numbers: UFPTI 0903-CN01
Study First Received: February 9, 2010
Last Updated: December 16, 2015

Keywords provided by University of Florida:
Proton Radiation
Central Nervous System Tumors

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Neoplasms
Neoplasms by Site
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases processed this record on May 22, 2017