Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization to death from any cause, or date of last follow-up, whichever occurs first. | Approximately end of year 6 (Study Completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G). | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Palma, MD, PhD | Contact | 519-685-8650 | David.Palma@lhsc.on.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer - Centre for the North | Not yet recruiting | Prince George | British Columbia | V2M 7E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39244532 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Chemotherapy | Drug | Pre-specified based on the standard of care approach for that patient. |
|
|
| Hormone therapy | Drug | Pre-specified based on the standard of care approach for that patient. |
|
|
| Immunotherapy | Drug | Pre-specified based on the standard of care approach for that patient. |
|
| Targeted Systemic Therapy | Drug | Pre-specified based on the standard of care approach for that patient. |
|
| Observation | Other | Pre-specified based on the standard of care approach for that patient. |
|
| Stereotactic Ablative Radiotherapy | Radiation | 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 | Procedure | 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 Radiation | 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. |
|
| 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). | 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. | 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). | During year 6 (follow-up year). |
| BC Cancer - Vancouver | Recruiting | Vancouver | British Columbia | V5Z 4C2 | Canada |
|
| London Regional Cancer Program of the Lawson Health Research Institute | Recruiting | London | Ontario | N6A 5W9 | Canada |
|
| Centre Hospitalier de l'Université de Montréal-CHUM | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
|
| Universitätsspital Zürich | Recruiting | Zurich | Switzerland |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D007167 | Immunotherapy |
| D019370 | Observation |
| D013514 | Surgical Procedures, Operative |
| D000078702 | Radiofrequency Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided