Actively Recruiting
Total RadIoTherapy of Oligometastatic caNcerS
Led by University of California, San Diego · Updated on 2025-10-14
300
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase III non-blinded randomized study evaluating patients with oligometastatic cancers (up to 10 metastases). Subjects are randomized 1:1 to stereotactic ablative radiotherapy (SABR) plus standard of care therapies versus standard of care therapies alone. The investigators will measure progression-free survival at 2 years based on the hypothesis that subjects treated with SABR plus standard of care will not experience disease progression for a longer period of time than subjects treated with standard of care alone. The investigators will also measure overall survival and safety of SABR, as well as biomarkers that may help predict, in the future, who will benefit from the SABR treatment.
CONDITIONS
Official Title
Total RadIoTherapy of Oligometastatic caNcerS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided.
- Willingness to comply with all study procedures and available for the entire study duration.
- Age 18 years or older.
- Eligible for standard systemic therapy and SABR to metastatic sites based on health and life expectancy.
- Histopathologic confirmation of a solid malignancy.
- Newly diagnosed or progressive metastases with 1 to 10 discrete distant metastases visible on imaging, with at least one outside the brain.
- New systemic therapy for metastatic disease started or resumed no more than 6 months before randomization.
- For those who can become pregnant: use of highly effective contraception for at least 1 month before screening and during active SABR treatment.
- For those who can cause pregnancy: use of condoms or other effective contraception methods with partner during active SABR treatment.
You will not qualify if you...
- Pregnancy.
- Contraindications to radiotherapy such as interstitial lung disease if thoracic radiation is planned, Crohn's disease if gastrointestinal tract will receive radiotherapy, active connective tissue disorders (e.g., scleroderma or uncontrolled lupus), or moderate/severe liver dysfunction (Child Pugh B or C) if liver metastases are present.
- Prior radiation therapy to treatment area that would exceed normal tissue dose constraints.
- Presence of malignant pleural effusion or malignant ascites.
- Leptomeningeal disease in the central nervous system.
- Metastatic disease at sites that cannot be safely treated with SABR at trial-specified doses.
- Any unresected metastasis larger than 5 cm in largest diameter or larger than 3 cm in the brain.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
T
Tyler Seibert, MD, PhD
CONTACT
R
Rana McKay, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here