A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor. (SABR-SYNC)

December 24, 2025 updated by: David Palma

This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease.

Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Prince George, British Columbia, Canada, V2M 7E9
        • Not yet recruiting
        • BC Cancer - Centre for the North
        • Principal Investigator:
          • Robert Olson, MD, MSc
      • Vancouver, British Columbia, Canada, V5Z 4C2
        • Recruiting
        • BC Cancer - Vancouver
        • Principal Investigator:
          • Srinivas Raman, MD
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Regional Cancer Program of the Lawson Health Research Institute
        • Contact:
        • Principal Investigator:
          • David Palma, MD, PhD
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal-CHUM
        • Contact:
        • Principal Investigator:
          • Toni Vu, MD, FRCP (C)
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • Universitatsspital Zurich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Willing to provide informed consent
  • Karnofsky performance status > 60
  • Life expectancy > 6 months
  • Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
  • Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present
  • Restaging completed within 12 weeks prior to randomization (see section 5.1)
  • For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
  • 10 or fewer lifetime metastases from the cancer for which participants are being enrolled

Exclusion Criteria:

  • Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
  • For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
  • Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with a member of the study steering committee.
  • Malignant pleural effusion
  • Inability to treat all sites of disease
  • Brain metastasis > 3 cm in size or a total volume of brain metastases greater than 30 cc.
  • Metastasis in the brainstem
  • Clinical or radiologic evidence of spinal cord compression
  • Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
Radiation: Palliative Radiotherapy
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Drug: Chemotherapy
Pre-specified based on the standard of care approach for that patient.
Other Names:
  • Cytotoxic Systemic Therapy
Drug: Hormone therapy
Pre-specified based on the standard of care approach for that patient.
Other Names:
  • Hormonal Systemic Therapy
Drug: Immunotherapy
Pre-specified based on the standard of care approach for that patient.
Drug: Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Other: Observation
Pre-specified based on the standard of care approach for that patient.
Experimental: Experimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
Radiation: Palliative Radiotherapy
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Drug: Chemotherapy
Pre-specified based on the standard of care approach for that patient.
Other Names:
  • Cytotoxic Systemic Therapy
Drug: Hormone therapy
Pre-specified based on the standard of care approach for that patient.
Other Names:
  • Hormonal Systemic Therapy
Drug: Immunotherapy
Pre-specified based on the standard of care approach for that patient.
Drug: Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Other: Observation
Pre-specified based on the standard of care approach for that patient.
Radiation: Stereotactic Ablative Radiotherapy

The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board.

Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).

Procedure: Surgery

Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.

The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.

Other: Radiofrequency Therapy (RFA)
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
Radiation: Fractionated Radiation

Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.

Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Approximately end of year 6 (Study Completion)
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
Approximately end of year 6 (Study Completion)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Time Frame: Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Time Frame: Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).
Time Frame: Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)
Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)
Time to next systemic therapy
Time Frame: From randomization to year 6 (study completion).
The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.
From randomization to year 6 (study completion).
Receipt of additional radiation during follow-up
Time Frame: During year 6 (follow-up year).
Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).
During year 6 (follow-up year).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
David Palma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ReDA 13176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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