Immediate simulation-free SBRT for people with up to five metastatic tumors
Pilot/Phase I Trial of Oligometastasis SBRT With Immediate, Simulation-Free Treatment Delivery (OLIGO-SWIFT)
This tests whether giving stereotactic body radiation therapy (SBRT) right away without a separate CT simulation helps people with up to five metastatic cancer spots get treatment faster.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07079098 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study tests a simulation-free workflow to deliver SBRT immediately for patients with oligometastatic cancer (up to five active lesions). Instead of the usual CT simulation and multi-day planning process, the team uses existing imaging and streamlined planning to try to shorten time to treatment and coordinate with systemic therapy. The study will enroll adults with ECOG performance status ≤2 who are candidates for SBRT and will track feasibility, time to treatment, treatment delivery accuracy, and early toxicity. Procedures and treatments are delivered at University Hospitals Seidman Cancer Center in Cleveland, Ohio.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed oligometastatic cancer (up to five active sites), ECOG ≤2, judged suitable for SBRT and able to attend the Cleveland treatment center are ideal candidates.
Not a fit: Patients with more than five metastatic sites, poor performance status, lesions unsuitable for SBRT, or who cannot pause concurrent systemic therapy are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could shorten the time to radiation treatment and allow symptoms to improve sooner while maintaining safe local control.
How similar studies have performed: SBRT for oligometastases has demonstrated benefit in multiple prior trials, but immediate, simulation-free delivery is a newer approach with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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. Exclusion Criteria: * 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 this trial is running
Cleveland, Ohio
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Henke, MD, MSCI — Case Comprehensive Cancer Center, University Hospitals
- Study coordinator: Lauren Henke, MD, MSCI
- Email: lauren.henke@uhhospitals.org
- Phone: (218) 234 -6429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.