Pilot/Phase I Trial of Oligometastasis SBRT With Immediate, Simulation-Free Treatment Delivery (OLIGO-SWIFT)
Case Comprehensive Cancer Center
Summary
This study is for participants whose cancer is oligometastatic, meaning it has spread to up to five spots in their body and their doctor recommends that they have stereotactic body radiation therapy (SBRT) to treat these cancer sites. SBRT is a type of radiation therapy that may help people with oligometastatic disease live longer without cancer progression. SBRT is usually given in addition to other cancer treatments, like chemotherapy, immunotherapy, or hormone therapy. Preparing for SBRT can take up to a week or longer. This can make it harder for participants to receive SBRT and coordinate care. This can also mean a longer time until symptoms from cancer sites improve. Doctors would like to treat oligometastatic cancers more quickly by reducing the time it takes to plan for the SBRT. The typical workflow for SBRT includes doctors doing a simulation which requires a CT (Computerized Tomography) 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. A way to reduce the planning time for SBRT is to use the CT scan (or other radiology scan types, like magnetic resonance imaging \[MRI\] or positron emission tomography \[PET\]) that participants had when their cancer was diagnosed to plan their SBRT. This eliminates the scheduling of an additional CT scan and the 5-10 day planning time. This is called CTsim-free (CT simulation-free) treatment planning. CT-sim-free radiation therapy planning has been shown to be effective in treating cancers that are causing pain in people with more advanced or widespread cancers. This study is being done to find out if it is safe and effective to use CTsim-free planning for SBRT to treat oligometastases.
Description
Oligometastatic disease (OMD) is a clinical evolution of cancer in which it has spread beyond the primary site but is not yet broadly metastatic. Oligometastases in radiation oncology are typically defined as being 1 to 5 metastatic lesions that can be safely treated with or without a controlled primary tumor. While multiple factors, including individual's overall health, tumor characteristics and treatment goals, play a crucial role in determining the most appropriate multidisciplinary approach to treating OMD, stereotactic body radiation therapy (SBRT) remains a cornerstone in the standard o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically, cytologically, or radiographically or confirmed cancer that is oligometastastatic (defined in this protocol as up to 5 active sites of disease at time of trial enrollment). Note that previous ablative therapy to the treatment site (excluding prior external beam radiation) is permitted, such as previous microwave ablation or radiofrequency ablation. * Age ≥18 years. * Performance status: Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 * Estimated life expectancy of at least 3 months * Participants must be considered…
Interventions
- OtherSimulation-free workflow
Pre-existing diagnostic images (CTs, PET/CTs, or MRIs) will be imported into the online treatment planning system called Ethos. The Ethos platform and online adaptive radiation therapy (ART) will be utilized at the time of treatment planning and the first (of five) fractions. Subsequent fractions will be delivered using standard image-guided radiotherapy (IGRT) or ART; this will be decided by the treating physician and institutional guidelines.
- RadiationSBRT
Participants will receive SBRT per standard of care in up to five fractions. Fractions will be delivered once daily or once every other day over a total period of one to two weeks.
Location
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio