Trial of Oligometastasis SBRT With Immediate, Simulation-Free Treatment Delivery (OLIGO-SWIFT)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07079098
Phase
PHASE1
Status
Recruiting
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Conditions

  • Oligometastasis
  • Oligometastatic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Simulation-free workflow — OTHER
    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.
  • SBRT — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Feb 27, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Simulation-free treatment delivery of SBRT

Primary Outcome Measure

Feasibility of a simulation-free adaptive radiotherapy approach for oligometastasis SBRT in clinical settings, as measured by successful completion of treatment [ Time Frame: Up to 2 weeks (timeframe of SBRT treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Lauren Henke, MD, MSCI
[email protected]
218-234-6429

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By research site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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