Total RadIoTherapy of Oligometastatic caNcerS
NCT06587490 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-10-14
Summary
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
- Oligometastatic Malignant Solid Neoplasm
Interventions
- RADIATION
-
stereotactic ablative radiotherapy
Stereotactic ablative radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.
Sponsors & Collaborators
-
University of California, San Diego
lead OTHER
Principal Investigators
-
Tyler Seibert · University of California, San Diego
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-12
- Primary Completion
- 2033-11-30
- Completion
- 2034-11-30
Countries
- United States
Study Locations
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