Recruiting
Phase 3

RadIoTherapy

Sponsor:

UCLA

Code:

NCT06587490

Conditions

Oligometastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

stereotactic ablative radiotherapy

Study Details

Brief 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

Study ID

NCT06587490

Start date

Nov 12, 2024

Status verified date

Oct, 2025

Completion date

Nov, 2034

Anticipated

Primary completion date

Nov, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SABR+SOC

stereotactic ablative radiotherapy (SABR) plus standard of care (SOC) cancer therapy

no intervention: SOC

standard of care (SOC) cancer therapy

Interventions

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.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tyler Seibert, MD, PhD

(858) 822-5354cancerCTO@health.ucsd.edu

Rana McKay, MD

(858) 822-5354cancerCTO@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

More Information

Sponsor

University of California, San Diego

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Stereotactic ablative radiotherapy
  • oligometastatic cancer
  • randomized phase III trial
  • biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-10-14.