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

Recruiting now · Phase 1

Conditions studied: Oligometastasis, Oligometastatic Disease

In brief

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 facts

Study ID: NCT07079098
Run by: Case Comprehensive Cancer Center
People needed: 15
Starts: 2026-02-27
Expected to finish: 2027-02-01
Last updated by the study team: 2026-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 a candidate for SBRT by the treating physician
Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation therapy and renewed no sooner than 1 week following radiation therapy, with the exception of endocrine therapies, which can continue through radiation treatment.
Participants must have the ability to understand and the willingness to sign a written informed consent document.
Participants must have a diagnostic CT, MRI, or PET/CT of the site(s) intended for treatment, with or without contrast, acquired no more than 30 days prior to study consent.

You may not qualify if…

Prior radiotherapy to any site overlapping with the projected site for protocol treatment.
Participants with isolated vertebral metastases except for sacral spine; participants with osseous spine disease can be treated upon this protocol, but those sites (cervical, thoracic, lumbar spine) are not permitted for treatment upon this study. Such participants could be enrolled for treatment to other, concurrent (e.g., visceral, or non-spine bone) disease on this study.
Pregnant or breastfeeding women are excluded from this study.
Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by the treating physician or protocol principal investigator (PI), documentation of this exception is sufficient in lieu of a pregnancy test.

Where it is running

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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