Immediate simulation-free SBRT for people with up to five metastatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.