Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Tyler Seibert (ucsd)
Headshot of Tyler Seibert
Tyler Seibert

Description

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 SABR 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.

Official Title

Total RadIoTherapy of Oligometastatic CaNcerS (TRITONS)

Details

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 their cancer. Stereotactic ablative radiotherapy (SABR) is highly effective, often achieving long-term local control. Previous studies demonstrated that SABR improves survival and quality of life in patients with oligometastatic cancer. However, these studies were small and not randomized. Thus, this randomized study will better evaluate the efficacy and safety of SABR in oligometastatic cancer.

Keywords

Oligometastatic Malignant Solid Neoplasm, Stereotactic ablative radiotherapy, oligometastatic cancer, randomized phase III trial, biomarkers

Eligibility

Location

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at University of California Health

  • Tyler Seibert (ucsd)
    Dr. Seibert is a clinical translational researcher working on imaging and genetics for cancer detection and treatment. More at SeibertLab.com.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tyler Seibert
ID
NCT06587490
Phase
Phase 3 Oligometastatic Malignant Solid Neoplasm Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated