This clinical trial tests how well adaptive proton therapy works to improve tumor coverage in treating children and young adults with sarcomas, bone and soft tissue tumors or Hodgkin's lymphoma. Proton Therapy is a type of radiation therapy that uses protons instead of x-rays to kill cancer cells and shrink tumors. The standard approach for planning proton therapy treatment involves imaging scans in the first week, and then radiation therapy is delivered over several weeks based on these scans. Pediatric solid tumors are historically known to be highly unpredictable and subject to daily changes. Doing more frequent imaging and adapting the treatment plan based on patients' most recent body changes may increase treatment accuracy and better protect healthy organs. Adaptive proton therapy may work well for the treatment of children and young adults with sarcomas, bone and soft tissue tumors or Hodgkin's lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07514819.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Approved
Contact: Ozgur Ates
Phone: 901-595-3300
PRIMARY OBJECTIVES:
I. Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.
II. Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.
SECONDARY OBJECTIVES:
I. Establish a cone beam computed tomography (CT) (CBCT)-based framework for quantifying body surface changes throughout the treatment course.
II. Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning.
EXPLORATORY OBJECTIVE:
I. Investigate the correlation between the extent of tissue discrepancies and changes in proton range, and deviations from the intended plan quality.
OUTLINE:
Patients undergo standard of care CT/magnetic resonance imaging (MRI) during week 1 for initial on-therapy planning. Patients then undergo proton therapy per standard of care, for 30 treatments, given over weeks 2-7, with CT and MRI scans every other week (weeks 2, 4, and 6). If the results of any CT/MRI scan determine changes to the target treatment area, a new treatment plan is created and implemented for the subsequent treatments. Patients who receive a new treatment plan at any point undergo weekly CT/MRI for the remainder of the proton therapy course.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorOzgur Ates
