Evaluation of Proton Therapy in Pediatric Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/23/2019 |
| Start Date: | August 1, 2017 |
| End Date: | July 2037 |
| Contact: | John T. Lucas, Jr., MS, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
Phase IV Clinical Trial of Proton Therapy in Pediatric Cancer
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.
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.
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.
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.
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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: John T. Lucas, Jr., MS, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
Click here to add this to my saved trials
