Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
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| ClinicalTrials.gov Identifier: NCT03721341 |
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Recruitment Status :
Recruiting
First Posted : October 26, 2018
Last Update Posted : July 18, 2022
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Sponsor:
David Palma
Collaborators:
Amsterdam University Medical Centre, VUmc Site
British Columbia Cancer - Centre for the North
Beaston West of Scotland Cancer Centre
London Health Sciences Centre
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Tumors | Radiation: Palliative Radiation Drug: Chemotherapy Drug: Immunotherapy Drug: Hormones Other: Observation Radiation: Stereotactic Ablative Radiotherapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 159 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10) |
| Actual Study Start Date : | February 22, 2019 |
| Estimated Primary Completion Date : | January 2029 |
| Estimated Study Completion Date : | January 2029 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
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Radiation: Palliative 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.
Other Name: Palliative Radiotherapy Drug: Chemotherapy Chemotherapy may be given as indicated. Drug: Immunotherapy Immunotherapy may be given as indicated. Drug: Hormones Hormones may be given as indicated. Other: Observation Observation only is acceptable if this is the standard practice. |
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Experimental: Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
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Drug: Chemotherapy
Chemotherapy may be given as indicated. Drug: Immunotherapy Immunotherapy may be given as indicated. Drug: Hormones Hormones may be given as indicated. Other: Observation Observation only is acceptable if this is the standard practice. Radiation: Stereotactic Ablative Radiotherapy 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). |
Primary Outcome Measures :
- Overall Survival at Study Completion [ Time Frame: At approximately end of year 6 (study completion) ]Time from randomization to death from any cause.
Secondary Outcome Measures :
- Progression-free Survival [ Time Frame: At approximately year 3, and end of year 6 (study completion) ]Time from randomization to disease progression at any site or death.
- Time from randomization to development of new metastatic lesions [ Time Frame: At approximately end of year 6 (study completion) ]New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.
- Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire [ Time Frame: At approximately end of year 6 (study completion) ]
- Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire [ Time Frame: At approximately end of year 6 (study completion) ]
- Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: End of years 1, 2, 3, 4, 5, and 6 (study completion) ]
- Overall Survival at midpoint of Study [ Time Frame: At approximately year 3 (midpoint) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 or older
- Willing to provide informed consent
- Karnofsky performance score greater than 60
- Life expectancy greater than 6 months
- Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
- Total number of metastases 4-10
- All sites of disease can be safely treated based on a pre-plan
Exclusion Criteria:
- Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract 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)
- 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 below. All such cases must be discussed with one of the study PIs.
- Malignant pleural effusion
- Inability to treat all sites of disease
- Any single metastasis greater than 5 cm in size.
- Any brain metastasis greater than 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
- Dominant brain metastasis requiring surgical decompression
- Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
- Pregnant or lactating women
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721341
Contacts
| Contact: David Palma, MD | 519-685-8650 | David.Palma@lhsc.on.ca |
Locations
| Australia, Victoria | |
| Alfred Health | Recruiting |
| Melbourne, Victoria, Australia, 3181 | |
| Contact: Robin Smith 61-3-9076-2360 r.smith@alfred.org.au | |
| Contact: Carole Owens 03 90762174 c.owens@alfred.org.au | |
| Principal Investigator: Sashendra Senthi | |
| Canada, British Columbia | |
| BC Cancer Agency, Vancouver Island Centre | Recruiting |
| Victoria, British Columbia, Canada, V8R 4X1 | |
| Contact: Shyann Hoppe, RN BScN | |
| Contact: Emily White | |
| Principal Investigator: Tanya S Berrang, FRCPC | |
| Canada, Nova Scotia | |
| Nova Scotia Health Authortiy | Recruiting |
| Halifax, Nova Scotia, Canada, B3S 0H6 | |
| Contact: Robin Simpson Robin.Simpson@nshealth.ca | |
| Contact: Kim Pitts Kim.Pitts@nshealth.ca | |
| Principal Investigator: Liam Mulroy | |
| Canada, Ontario | |
| Grand River Hospital | Recruiting |
| Kitchener, Ontario, Canada, N2G 1G3 | |
| Contact: Carla Girolametto 519-749-4300 ext 2307 carla.girolametto@grhosp.on.ca | |
| Contact: Elyse Wellhauser 519-749-4370 ext 2447 Elyse.Wellhauser@grhosp.on.ca | |
| Principal Investigator: Darin Gopaul, FRCPC | |
| London Regional Cancer Program of the Lawson Health Research Institute | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: David Palma, MD 519-685-8650 David.Palma@lhsc.on.ca | |
| Principal Investigator: David Palma, MD, PhD | |
| Trillium Health Partners-Credit Valley Hospital | Suspended |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Niagra Health System | Recruiting |
| St. Catharines, Ontario, Canada, L2S 0A9 | |
| Contact: Coreen Corning 905 684-7271 ext 45703 Coreen.Corning@niagarahealth.on.ca | |
| Contact: Khadija Al-Harazi 905 684-7271 ext 45703 Khadija.Al-Harazi@niagarahealth.on.ca | |
| Principal Investigator: Abhirami Hallock, FRCPC | |
| Health Sciences North | Recruiting |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Contact: Laura Ricard 705-522-6237 ext 2615 laricard@hsnsudbury.ca | |
| Principal Investigator: Andrew Pearce | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Jessy Abed, MRT(T), MHSc. 416-946-4501 ext 5881 Jessy.Abed@rmp.uhn.ca | |
| Contact: William Tang 416-946-4501 william.tang@RMP.uhn.ca | |
| Principal Investigator: Aisling Barry, MRCPI,FFRRCSI | |
| Sub-Investigator: Meredith Giuliani, MBBS,FRCPC | |
| Canada, Quebec | |
| Centre hospitalier de l'Université de Montréal-CHUM | Recruiting |
| Montréal, Quebec, Canada, H2X 0C1 | |
| Contact: Diane Trudel, RN 514-890-8000 ext 11181 diane.dt.trudel.chum@ssss.gouv.qc.ca | |
| Contact: Chantal Lafleur 514-890-8000 chantal.lafleur.chum@ssss.gouv.qc.ca | |
| Principal Investigator: Houda Bahig | |
| Sub-Investigator: Philip Wong | |
| Netherlands | |
| VU University Medical Centre | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Suresh Senan +31-20-444 1571 s.senan@vumc.nl | |
| Contact: Famke Scheiders 020- 444 5851/ 020- 444 1571 f.schneiders@amsterdamumc.nl | |
| Switzerland | |
| University Hospital of Zürich | Recruiting |
| Zürich, Switzerland, 8091 | |
| Contact: Cornelia Schaefer 41 44 255 37 68 Cornelia.Schaefer@usz.ch | |
| Principal Investigator: Matthias Guckenberge | |
| United Kingdom | |
| Western General Hospital | Recruiting |
| Edinburgh, United Kingdom, EH4 2XU | |
| Contact: Magdalena Patrzalek Magdalena.Patrzalek@nhslothian.scot.nhs.uk | |
| Principal Investigator: Stephen Harrow | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Contact: Maria Nicol 0044(0)1413017223 Maria.Nicol@ggc.scot.nhs.uk | |
| Contact: Austin McInnes 0044(0)1413017223 Austin.McInnes@Glasgow.ac.uk | |
| Principal Investigator: Stephen McKay, FRCR | |
Sponsors and Collaborators
David Palma
Amsterdam University Medical Centre, VUmc Site
British Columbia Cancer - Centre for the North
Beaston West of Scotland Cancer Centre
London Health Sciences Centre
Investigators
| Principal Investigator: | David Palma, MD | London Health Sciences Centre, Lawson Health Research Institute | |
| Principal Investigator: | Suresh Senan, MRCP, FRCR | Amsterdam University Medical Centre, VUmc Site | |
| Principal Investigator: | Robert Olson, MD | British Columbia Cancer - Centre for the North | |
| Principal Investigator: | Stephen Harrow, MB ChB | Beaston West of Scotland Cancer Centre |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Palma, Principal Investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT03721341 |
| Other Study ID Numbers: |
SABR-COMET 10 |
| First Posted: | October 26, 2018 Key Record Dates |
| Last Update Posted: | July 18, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |