Total RadIoTherapy of Oligometastatic caNcerS

NCT06587490 | Recruiting Phase 3 DMC

• 1 other identifier: 810616
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Rate of Progression Free Survival in the two study arms

  2 years

Secondary Outcomes (1)

• All-grade and grade ≥3 toxicity

  2 years

Study Arms (2)

SABR+SOC

EXPERIMENTAL

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

Radiation: stereotactic ablative radiotherapy

SOC

NO INTERVENTION

standard of care (SOC) cancer therapy

Interventions

stereotactic ablative radiotherapy RADIATION

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.

Also known as: SABR

SABR+SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Age at least 18 years.
• 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).
• Histopathologic confirmation of a solid malignancy.
• 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.
• New systemic therapy for metastatic disease initiated no more than 6 months prior to randomization.
• 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.
• For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment.

You may not qualify if:

• Pregnancy.
• 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.
• 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.
• Malignant pleural effusion or malignant ascites.
• Leptomeningeal disease in the central nervous system.
• Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
• Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Study Officials

• Tyler Seibert

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Seibert, MD, PhD

CONTACT

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

Rana McKay, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): November 1, 2034
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)