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

University of Florida

Status: Completed

Conditions: Central Nervous System Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT01067196

IRB201701741

UFPTI 0903-CN01 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 500 patients

Sex: All

Ages: 1 day to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Observation and quality of life

Description:

Central Nervous System Tumors