Evaluation of Proton Therapy in Pediatric Cancer Patients

NCT03223766 | Active Not Recruiting

• 1 other identifier: SJPROTON1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor

Keywords

Proton therapy; Long-term effects

Outcome Measures

Primary Outcomes (1)

• Incidence of radiation-associated non-hematologic toxicities

  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.

  From baseline through 10 years

Study Arms (1)

Participants

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms

Study Officials

• John T. Lucas, Jr., MS, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: August 1, 2017
• Primary Completion (Estimated): July 1, 2037
• Study Completion (Estimated): July 1, 2037
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)