Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| British Columbia Cancer - Centre for the North | UNKNOWN |
| Beaston West of Scotland Cancer Centre | UNKNOWN |
Not provided
Not provided
Not provided
In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm | Active Comparator | Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist. |
|
| Stereotactic Arm | Experimental | Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Radiation | Radiation | Investigators should follow the principles of palliative radiotherapy as per the individual institution in order to alleviate symptoms or prevent complications. If radiotherapy is indicated, recommended doses are 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at Study Completion | Time from randomization to death from any cause. | At approximately end of year 6 (study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Time from randomization to disease progression at any site or death. | At approximately year 3, and end of year 6 (study completion) |
| Time from randomization to development of new metastatic lesions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Palma, MD | London Health Sciences Centre, Lawson Health Research Institute | Principal Investigator |
| Suresh Senan, MRCP, FRCR | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Robert Olson, MD | British Columbia Cancer - Centre for the North | Principal Investigator |
| Stephen Harrow, MB ChB | Beaston West of Scotland Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Health | Melbourne | Victoria | 3181 | Australia | ||
| BC Cancer Agency, Vancouver Island Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33608212 | Derived | Mattes MD, Eubank TD, Almubarak M, Wen S, Marano GD, Jacobson GM, Ma PC. A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer. Clin Lung Cancer. 2021 Jul;22(4):268-273. doi: 10.1016/j.cllc.2021.01.012. Epub 2021 Jan 25. | |
| 31426760 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| London Health Sciences Centre |
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Chemotherapy | Drug | Chemotherapy may be given as indicated. |
|
| Immunotherapy | Drug | Immunotherapy may be given as indicated. |
|
| Hormones | Drug | Hormones may be given as indicated. |
|
| Observation | Other | Observation only is acceptable if this is the standard practice. |
|
| Stereotactic Ablative Radiotherapy | Radiation | Total dose of radiation and number of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every 2 days), or 35 Gy in 5 fractions (daily). |
|
New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.
| At approximately end of year 6 (study completion) |
| Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire | At approximately end of year 6 (study completion) |
| Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire | At approximately end of year 6 (study completion) |
| Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | End of years 1, 2, 3, 4, 5, and 6 (study completion) |
| Overall Survival at midpoint of Study | At approximately year 3 (midpoint) |
| Victoria |
| British Columbia |
| V8R 4X1 |
| Canada |
| Nova Scotia Health Authortiy | Halifax | Nova Scotia | B3S 0H6 | Canada |
| Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Grand River Hospital | Kitchener | Ontario | N2G 1G3 | Canada |
| London Regional Cancer Program of the Lawson Health Research Institute | London | Ontario | N6A 5W9 | Canada |
| Trillium Health Partners-Credit Valley Hospital | Mississauga | Ontario | L5M 2N1 | Canada |
| Niagra Health System | St. Catharines | Ontario | L2S 0A9 | Canada |
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| Centre hospitalier de l'Université de Montréal-CHUM | Montreal | Quebec | H2X 0C1 | Canada |
| VU University Medical Centre | Amsterdam | Netherlands |
| University Hospital of Zürich | Zurich | 8091 | Switzerland |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Palma DA, Olson R, Harrow S, Correa RJM, Schneiders F, Haasbeek CJA, Rodrigues GB, Lock M, Yaremko BP, Bauman GS, Ahmad B, Schellenberg D, Liu M, Gaede S, Laba J, Mulroy L, Senthi S, Louie AV, Swaminath A, Chalmers A, Warner A, Slotman BJ, de Gruijl TD, Allan A, Senan S. Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial. BMC Cancer. 2019 Aug 19;19(1):816. doi: 10.1186/s12885-019-5977-6. |
| 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 |
| D006728 | Hormones |
| D019370 | Observation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided