Evaluation of Proton Therapy in Pediatric Cancer Patients

Active, not recruiting

• Conditions: Tumor

• Registration Number: NCT03223766
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

This is a Phase IV clinical trial observing and evaluating the safety of proton therapy in children. Protocol therapy is not being done as part of this clinical trial. The radiation targeting, planning, prescribed dose, fractionation, schedule, and use of other forms of therapy will be done per other therapeutic protocols at St. Jude Children's Research Hospital (SJCRH) at the discretion of the treating physicians associated with those trials.

Detailed Description

For the clinical trial being described in this registration, participants will be observed to collect data for baseline assessment of disease and patient characteristics. This will be done before proton therapy on other trials followed by serial standard-of-care clinical assessments to evaluate acute and late complications, disease control, treatment-related mortality, and overall survival.

PRIMARY OBJECTIVE:

* To estimate the incidence of radiation associated grade 3 and grade 4 non-hematologic toxicities at 1, 3, 5, and 10 years in a radiated region specific manner after the initiation of proton therapy.

SECONDARY OBJECTIVES:

* To estimate the incidence of necrosis, vasculopathy, and symptomatic and permanent neurologic deficits at 1, 3, 5, and 10 years after the initiation of proton therapy in children treated for central nervous system (CNS) tumors in an irradiated region directed manner.

* To estimate the incidence of treatment-related mortality at 5 and 10 years after the initiation of proton therapy.

* To estimate the incidence of subsequent malignancies at 5 and 10 years after the initiation of proton therapy in an irradiated region directed manner.

* To estimate the incidence of fracture and osteonecrosis at 1, 3, 5, and 10 years after the initiation of proton therapy in children treated for musculoskeletal tumors in an irradiated region directed manner.

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2017-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2037-07
• Study Completion: 2037-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• The patient is planned for treatment or has been treated with proton therapy at St. Jude Children's Research Hospital on or after November 18, 2015.

Exclusion Criteria

• Patients who are currently pregnant will not be enrolled in the study as radiation has teratogenic or abortifacient effects. In the rare case that a patient was previously pregnant as a young adult, the patient will be considered eligible for enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of radiation-associated non-hematologic toxicities	From baseline through 10 years	All Grade 3 and Grade 4 non-hematologic toxicities will be reviewed to determine attribution to proton therapy given in other clinical trials at SJCRH and the number reported.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States