Treatment for oligometastatic cancers using stereotactic ablative radiotherapy
Total RadIoTherapy of Oligometastatic caNcerS (TRITONS)
PHASE3 · University of California, San Diego · NCT06587490
This study is testing if adding a special type of radiation treatment to standard care can help people with a few cancer spread spots live longer and feel better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Drugs / interventions | radiation, chemotherapy, immunotherapy |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06587490 on ClinicalTrials.gov |
What this trial studies
This Phase III randomized study evaluates the effectiveness of stereotactic ablative radiotherapy (SABR) in patients with oligometastatic cancers, where participants are assigned to receive either SABR plus standard care or SABR alone. The primary goal is to measure progression-free survival over two years, with secondary outcomes including overall survival, safety, and the identification of biomarkers that may predict treatment benefits. By focusing on patients with up to ten metastases, the study aims to determine if combining SABR with standard therapies can significantly delay disease progression and improve quality of life. This research builds on previous findings that suggested SABR could enhance survival in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed solid malignancies and 1 to 10 visible distant metastases.
Not a fit: Patients with pregnancy or contraindications to SABR or systemic therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve progression-free survival and quality of life for patients with oligometastatic cancer.
How similar studies have performed: Previous studies have shown promising results for SABR in oligometastatic cancer, but this is a novel randomized approach aimed at providing more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 lesion must be outside the brain parenchyma) for which a new line of systemic therapy is started or resumed. 7. New systemic therapy for metastatic disease initiated no more than 6 months prior to randomization. 8. For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during active SABR treatment. 9. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment. Exclusion Criteria: 1. Pregnancy. 2. Contraindications to radiotherapy, including interstitial lung disease if thoracic radiation is planned; Crohn's disease if the gastrointestinal tract will receive radiotherapy; active connective tissue disorders such as scleroderma or uncontrolled lupus; moderate or severe liver dysfunction (Child Pugh B or C) if the patient has liver metastases. 3. Prior radiation therapy to an area requiring treatment in the present study, if the composite dose would exceed normal tissue constraints specified by UC San Diego Radiotherapy Standards and Guidelines (published by the Department of Radiation Medicine and Applied Sciences), or by local institutional radiotherapy dose constraints for safety and efficacy. 4. Malignant pleural effusion or malignant ascites. 5. Leptomeningeal disease in the central nervous system. 6. Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial. 7. Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.
Where this trial is running
La Jolla, California
- University of California, San Diego — La Jolla, California, United States (RECRUITING)
Study contacts
- Principal investigator: Tyler Seibert — University of California, San Diego
- Study coordinator: Tyler Seibert, MD, PhD
- Email: cancerCTO@health.ucsd.edu
- Phone: (858) 822-5354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oligometastatic Malignant Solid Neoplasm, Stereotactic ablative radiotherapy, oligometastatic cancer, randomized phase III trial, biomarkers