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


N/A
N/A
20 Years
Open (Enrolling)
Both
Central Nervous System Tumors

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Trial Information

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


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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

5.4 years after treatment completion

Safety Issue:

Yes

Principal Investigator

Daniel J. Indelicato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0903-CN01

NCT ID:

NCT01067196

Start Date:

February 2010

Completion Date:

January 2028

Related Keywords:

  • Central Nervous System Tumors
  • Proton Radiation
  • Central Nervous System Tumors
  • Brain
  • Spine
  • Cancer
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206