Metastatic TumorPhase 3SABR-SYNCNCT05717166
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
A Phase 3 study testing Palliative Radiotherapy, Chemotherapy and Hormone therapy in people with Metastatic Tumor, run by David Palma at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Tumor
- What is being tested?
- Palliative Radiotherapy, Chemotherapy and Hormone therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Oct 2023to Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Canada4 sites, 4 recruiting
- Recruiting
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 5W9
David Palma, MD, PhD, 519-685-8650, David.Palma@lhsc.on.ca
David Palma, MD, PhD
- Recruiting
Centre Hospitalier de l'Université de Montréal-CHUM
Montreal, Quebec, H2X 0C1
Toni Vu, 514-575-7690, thi_trinh_thuc.vu.med@ssss.gouv.qc.ca
Toni Vu, MD, FRCP (C)
- Not yet recruiting
BC Cancer - Centre for the North
Prince George, British Columbia, V2M 7E9
Robert Olson, MD, MSc
- Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4C2
Tina Zhang, MD, 604-877-6000, srinivas.raman@bccancer.bc.ca
Srinivas Raman, MD
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich
Matthias Guckenberger, MD, +41 44 255 35 66, Matthias.Guckenberger@usz.ch
About this study
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).
- Conditions
- Metastatic Tumor
- Being tested
- Palliative Radiotherapy, Chemotherapy, Hormone therapy, Immunotherapy, Targeted Systemic Therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative RadiotherapyRadiation
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.
ChemotherapyDrug
Also called Cytotoxic Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Hormone therapyDrug
Also called Hormonal Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
ImmunotherapyDrug
Pre-specified based on the standard of care approach for that patient.
Targeted Systemic TherapyDrug
Pre-specified based on the standard of care approach for that patient.
ObservationOther
Pre-specified based on the standard of care approach for that patient.
Stereotactic Ablative RadiotherapyRadiation
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).
SurgeryProcedure or 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.
Radiofrequency Therapy (RFA)Other
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.
Fractionated RadiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm (Arm 1) | Active comparator | 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. Receives: Radiation: Palliative Radiotherapy; Drug: Chemotherapy; Drug: Hormone therapy; Drug: Immunotherapy; Drug: Targeted Systemic Therapy; Other: Observation |
| Experimental Arm (Arm 2) | Experimental | 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. Receives: Radiation: Palliative Radiotherapy; Drug: Chemotherapy; Drug: Hormone therapy; Drug: Immunotherapy; Drug: Targeted Systemic Therapy; Other: Observation; Radiation: Stereotactic Ablative Radiotherapy; Procedure: Surgery; Other: Radiofrequency Therapy (RFA); Radiation: Fractionated Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
Measured: Approximately end of year 6 (Study Completion)
Secondary outcomes (5)
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Measured: 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).
Measured: 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).
Measured: 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
The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.
Measured: From randomization to year 6 (study completion).
Receipt of additional radiation during follow-up
Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).
Measured: During year 6 (follow-up year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Oct 2023
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Palma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717166
- Sponsor's protocol ID
- ReDA 13176
- Acronym
- SABR-SYNC
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palma DA, Giuliani ME, Correa RJM, Schneiders FL, Harrow S, Guckenberger M, Zhang T, Bahig H, Senthi S, Chung P, Olson R, Lock M, Raman S, Bauman GS, Lok BH, Laba JM, Glicksman RM, Nguyen TK, Lang P, Helou J, Goodman CD, Mendez LC, van Rossum PSN, Warner A, Gaede S, Allan AL. A randomized phase III trial of stereotactic ablative radiotherapy for patients with up to 10 oligometastases and a synchronous primary tumor (SABR-SYNC): study protocol. BMC Palliat Care. 2024 Sep 7;23(1):223. doi: 10.1186/s12904-024-01548-7.
PubMed 39244532
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
- ClinicalTrials.gov ID
- NCT05717166
- Acronym / sponsor ID
- SABR-SYNC / ReDA 13176
- Conditions
- Metastatic Tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- David PalmaUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm (Arm 1) | Active comparator | Radiation: Palliative Radiotherapy, Drug: Chemotherapy, Drug: Hormone therapy, Drug: Immunotherapy, Drug: Targeted Systemic Therapy, Other: ObservationRadiotherapy 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. |
| Experimental Arm (Arm 2) | Experimental | Radiation: Palliative Radiotherapy, Drug: Chemotherapy, Drug: Hormone therapy, Drug: Immunotherapy, Drug: Targeted Systemic Therapy, Other: Observation, Radiation: Stereotactic Ablative Radiotherapy, Procedure: Surgery, Other: Radiofrequency Therapy (RFA), Radiation: Fractionated RadiationConsists 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative RadiotherapyRadiotherapy 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. | Radiation | Experimental Arm (Arm 2), Standard Arm (Arm 1) |
| ChemotherapyAlso: Cytotoxic Systemic TherapyPre-specified based on the standard of care approach for that patient. | Drug | Experimental Arm (Arm 2), Standard Arm (Arm 1) |
| Hormone therapyAlso: Hormonal Systemic TherapyPre-specified based on the standard of care approach for that patient. | Drug | Experimental Arm (Arm 2), Standard Arm (Arm 1) |
| ImmunotherapyPre-specified based on the standard of care approach for that patient. | Drug | Experimental Arm (Arm 2), Standard Arm (Arm 1) |
| Targeted Systemic TherapyPre-specified based on the standard of care approach for that patient. | Drug | Experimental Arm (Arm 2), Standard Arm (Arm 1) |
| ObservationPre-specified based on the standard of care approach for that patient. | Other | Experimental Arm (Arm 2), Standard Arm (Arm 1) |
| Stereotactic Ablative RadiotherapyThe 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). | Radiation | Experimental Arm (Arm 2) |
| SurgeryTreatment 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. | Procedure or surgery | Experimental Arm (Arm 2) |
| 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. | Other | Experimental Arm (Arm 2) |
| Fractionated RadiationTreatment 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. | Radiation | Experimental Arm (Arm 2) |
Primary outcome
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.
5 secondary outcomes
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 (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)
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)
Time to next systemic therapy
Time frame: From randomization to year 6 (study completion).
Receipt of additional radiation during follow-up
Time frame: During year 6 (follow-up year).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 39244532Palma DA, Giuliani ME, Correa RJM, Schneiders FL, Harrow S, Guckenberger M, Zhang T, Bahig H, Senthi S, Chung P, Olson R, Lock M, Raman S, Bauman GS, Lok BH, Laba JM, Glicksman RM, Nguyen TK, Lang P, Helou J, Goodman CD, Mendez LC, van Rossum PSN, Warner A, Gaede S, Allan AL. A randomized phase III trial of stereotactic ablative radiotherapy for patients with up to 10 oligometastases and a synchronous primary tumor (SABR-SYNC): study protocol. BMC Palliat Care. 2024 Sep 7;23(1):223. doi: 10.1186/s12904-024-01548-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palliative Radiotherapy, Chemotherapy and Hormone therapy in people with Metastatic Tumor, run by David Palma at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Palma, MD, PhD (519-685-8650, David.Palma@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Approximately end of year 6 (Study Completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.