Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-01 @ 8:03 PM
Study NCT ID:
NCT03223766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Proton Therapy in Pediatric Cancer Patients
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Phase IV Clinical Trial of Proton Therapy in Pediatric Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: