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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067196
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease
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.

Study Type : Observational
Actual Enrollment : 442 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Observation and quality of life
Central Nervous System Tumors

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: University of Florida Identifier: NCT01067196     History of Changes
Other Study ID Numbers: IRB201701741
UFPTI 0903-CN01 ( Other Identifier: University of Florida Project # )
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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