A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
NCT ID: NCT05717166
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2023-10-06
2029-04-30
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Chemotherapy
Pre-specified based on the standard of care approach for that patient.
Hormone therapy
Pre-specified based on the standard of care approach for that patient.
Immunotherapy
Pre-specified based on the standard of care approach for that patient.
Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Observation
Pre-specified based on the standard of care approach for that patient.
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.
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.
Chemotherapy
Pre-specified based on the standard of care approach for that patient.
Hormone therapy
Pre-specified based on the standard of care approach for that patient.
Immunotherapy
Pre-specified based on the standard of care approach for that patient.
Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Observation
Pre-specified based on the standard of care approach for that patient.
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).
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)
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 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.
Interventions
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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.
Chemotherapy
Pre-specified based on the standard of care approach for that patient.
Hormone therapy
Pre-specified based on the standard of care approach for that patient.
Immunotherapy
Pre-specified based on the standard of care approach for that patient.
Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Observation
Pre-specified based on the standard of care approach for that patient.
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).
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)
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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David Palma
OTHER
Responsible Party
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David Palma
Principal Investigator
Locations
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BC Cancer - Centre for the North
Prince George, British Columbia, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, Canada
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-CHUM
Montreal, Quebec, Canada
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Tina Zhang, MD
Role: primary
David Palma, MD, PhD
Role: primary
Toni Vu
Role: primary
Matthias Guckenberger, MD
Role: primary
References
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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.
Other Identifiers
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ReDA 13176
Identifier Type: -
Identifier Source: org_study_id