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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01067196
Acronym
CN01
Enrollment
500
Registered
2010-02-11
Start date
2010-02-28
Completion date
2022-05-21
Last updated
2022-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Tumors

Keywords

Proton Radiation, Central Nervous System (CNS) Tumors, Brain, Spine, Cancer, Radiation Therapy (RT)

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 20 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Measure late effects of proton therapy on pediatric patients with CNS tumors5.4 years after treatment completion

Secondary

MeasureTime frame
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.12 years after treatment completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026