NCT06587490

Total RadIoTherapy of Oligometastatic caNcerS

Total RadIoTherapy of Oligometastatic caNcerS (TRITONS)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Oligometastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-12
• Primary completion: 2033-11-01
• Completion: 2034-11-01
• First posted: 2024-09-19
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States