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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01067196
First received: February 9, 2010
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: February 2010
Estimated Study Completion Date: January 2028
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated at a radiation oncology clinic

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.

Exclusion Criteria:

  • Prior radiation therapy.
  • Evidence of metastases outside the central nervous system.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067196

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Daniel J. Indelicato, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Daniel J. Indelicato, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01067196     History of Changes
Other Study ID Numbers: UFPTI 0903-CN01
Study First Received: February 9, 2010
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Brain Neoplasms
Neoplasms by Site
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014