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

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01067196
First received: February 9, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes

February 9, 2010
March 11, 2013
February 2010
January 2021   (final data collection date for primary outcome measure)
Measure late effects of proton therapy on pediatric patients with CNS tumors [ Time Frame: 5.4 years after treatment completion ] [ Designated as safety issue: Yes ]
Measure late effects of proton therapy on pediatric patients with CNS tumors [ Time Frame: 5.4 years after treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01067196 on ClinicalTrials.gov Archive Site
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival. [ Time Frame: 12 years after treatment completion ] [ Designated as safety issue: No ]
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival. [ Time Frame: 12 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
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.

Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated at a radiation oncology clinic
Central Nervous System Tumors
Not Provided
Observation and quality of life
Central Nervous System Tumors

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2028
January 2021   (final data collection date for primary outcome measure)

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.

Exclusion Criteria:

  • Prior radiation therapy.
  • Evidence of metastases outside the central nervous system.
Both
up to 20 Years
No
Contact: Intake Coordinator 877-686-6009
United States
 
NCT01067196
UFPTI 0903-CN01
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Daniel J. Indelicato, MD University of Florida Proton Therapy Institute
University of Florida
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP