This clinical trial tests whether it's feasible to use previously collected diagnostic imaging scans (computed tomography [CT], positron emission tomography [PET]/CT, or magnetic resonance imaging [MRI]) to develop and deliver a stereotactic body radiation therapy (SBRT) treatment plan to patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and that is causing abdominal pain. Some cancers can cause pain in the abdominal area if the cancer is pressing on nerves around the stomach. Doctors can help ease this pain by giving SBRT. SBRT is a type of radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Preparing for SBRT typically requires a process called simulation, which requires a CT scan. The CT scan is used to create a treatment plan. It can take time to schedule this CT scan and then it normally takes another 5-10 days to create a treatment plan. This long process can make it harder for patients to receive SBRT and coordinate care. One way to reduce the planning time for SBRT is to use the imaging scans (CT, PET/CT, or MRI) that were already performed at the time of diagnosis to plan SBRT. This eliminates the scheduling of an additional scan and the 5-10 day planning time. This new simulation-free approach may be a feasible way to develop and deliver an SBRT treatment plan to patients with cancer-related abdominal pain.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07117032.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Approved
Contact: Lauren Elizabeth Henke
Phone: 218-234-6429
PRIMARY OBJECTIVE:
I. To demonstrate the feasibility and safety of the simulation-free adaptive radiotherapy workflow for celiac plexus SBRT for clinical use.
EXPLORATORY OBJECTIVES:
I. To report pre-planning as well as workflow delivery/on-board time needed during the treatment session to deliver celiac plexus SBRT using a simulation-free, adaptive radiotherapy workflow.
II. To determine the average time required for each component of the simulation-free adaptive radiotherapy (ART) workflow, including but not limited to: plan generation using diagnostic imaging, pre-treatment activities (e.g., on-table patient setup/imaging, dose prediction, segmentation of daily contours, plan optimization and evaluation), and treatment delivery.
III. Dosimetric comparison of radiation plans created on traditional simulation helical CT images with those created using the simulation-free ART workflow (i.e., comparison of target coverage, sparing of organs-at-risk).
IV. Determine the frequency of online adaptation within the simulation-free workflow.
V. To report overall patient satisfaction with celiac plexus SBRT using a simulation-free, adaptive radiotherapy workflow.
VI. To report the change in the pain scale (Brief Pain Inventory) and pain medications (morphine equivalents) use 6 weeks after simulation (sim)-free celiac plexus SBRT.
VII. To report the overall cost of simulation free workflow compared to select retrospective cases treated on conventional workflow.
VIII. Determine mean difference between diagnostic and ETHOS plans for select organs at risk.
OUTLINE:
Patients undergo a single fraction of simulation-free SBRT. Patients also undergo CT on study. Patients may undergo routine diagnostic CT, PET/CT, or MRI during screening.
After completion of study intervention, patients are followed up at 6 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorLauren Elizabeth Henke
