Total RadIoTherapy of Oligometastatic caNcerS (TRITONS)
University of California, San Diego
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.
Description
Patients with metastatic solid malignancies are generally deemed incurable. Systemic therapies (cytotoxic chemotherapy, immunotherapy, hormonal therapy, etc.) can be effective for prolonging life, but cancers will eventually become resistant, prompting transition to second-line therapies that are often more toxic and/or more expensive with diminishing oncologic benefit. In patients with relatively few detectable metastases, SABR to visible tumors may substantially delay progression and thus improve quality of life. Unfortunately, most patients with metastatic disease will eventually die from t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age at least 18 years. 4. Deemed eligible to undergo standard systemic therapy and SABR to metastatic sites (i.e., patient has adequate health and life expectancy, and treatment is not contraindicated). 5. Histopathologic confirmation of a solid malignancy. 6. Newly diagnosed or progressive metastasis (at least 1 and no more than 10 discrete distant metastases visible on staging imaging. At least one metastatic…
Interventions
- Radiationstereotactic 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.
Location
- University of California, San DiegoLa Jolla, California