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Evaluation of Proton Therapy in Pediatric Cancer Patients

Phase IV Clinical Trial of Proton Therapy in Pediatric Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03223766
Enrollment
1000
Registered
2017-07-21
Start date
2017-08-01
Completion date
2037-07-01
Last updated
2026-06-17

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

Conditions

Tumor

Keywords

Proton therapy, Long-term effects

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.

Interventions

None listed

Sponsors

St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of radiation-associated non-hematologic toxicitiesFrom baseline through 10 yearsAll 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJohn T. Lucas, Jr., MS, MD

St. Jude Children's Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026