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Evaluation of Proton Therapy in Pediatric Cancer Patients

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ClinicalTrials.gov Identifier: NCT03223766
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Tumor

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 Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Clinical Trial of Proton Therapy in Pediatric Cancer
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 2037
Estimated Study Completion Date : July 2037

Group/Cohort
Participants
Participants will be those enrolled to receive proton therapy on other protocols at SJCRH on or after November 18, 2015.



Primary Outcome Measures :
  1. Incidence of radiation-associated non-hematologic toxicities [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants will be patients at St. Jude Children's Research Hospital. They must meet eligibility criteria to be considered for enrollment. No one group (based on gender, race or ethnicity) will be targeted or excluded.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223766


Contacts
Contact: John T. Lucas, Jr., MS, MD 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: John T. Lucas, Jr., MS, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: John T. Lucas, Jr., MS, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: John T. Lucas, Jr., MS, MD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03223766     History of Changes
Other Study ID Numbers: SJPROTON1
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Proton therapy
Long-term effects