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

NCT07079098 | Recruiting Phase 1 DMC

• 1 other identifier: CASE2Y25
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oligometastasis; Oligometastatic Disease

Keywords

Stereotactic Body Radiation Therapy; SBRT

Outcome Measures

Primary Outcomes (2)

• Feasibility of a simulation-free adaptive radiotherapy approach for oligometastasis SBRT in clinical settings, as measured by successful completion of treatment

  Successful completion of treatment will be determined by first-fraction radiation delivery occurring in the first on-table treatment attempt for at least 70% of participants with simulation-free plans meeting dosimetric requirements.

  Up to 2 weeks (timeframe of SBRT treatment)

• Feasibility of a simulation-free adaptive radiotherapy approach for oligometastasis SBRT in clinical settings, as measured by pre-treatment quality assurance clinical gamma passing index

  A pre-treatment quality assurance clinical gamma passing index that is less than or equal to 2%/2mm will be considered successful.

  Up to 2 weeks (timeframe of SBRT treatment)

Study Arms (1)

Simulation-free treatment delivery of SBRT

EXPERIMENTAL

Other: Simulation-free workflow; Radiation: SBRT

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.

Simulation-free treatment delivery of SBRT

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.

Simulation-free treatment delivery of SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

Study Officials

• Lauren Henke, MD, MSCI

  Case Comprehensive Cancer Center, University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Henke, MD, MSCI

CONTACT

(218) 234 -6429; lauren.henke@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)