Outcomes Study of Late Effects After Proton RT 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.

Completed

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Key information

Conditions

Central Nervous System Tumors Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

1 day–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 5.4 years after treatment completion

Secondary outcomes

Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.

Time frame: 12 years after treatment completion

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: CN01

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2022
First posted: Feb 11, 2010
Registry last updated: Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed