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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer (SABR-COMET-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03862911
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : May 26, 2020
Sponsor:
Collaborators:
London Regional Cancer Program, Canada
Beatson Institute for Cancer Research, Scotland
The Alfred
Beacon Hospital, Ireland
Information provided by (Responsible Party):
Robert Olson, British Columbia Cancer Agency

Brief Summary:
Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques. SABR is non-invasive and delivered on an outpatient basis. The purpose of this study is to compare the effect of SABR, relative to standard of care (SOC) alone, on overall survival, progression-free survival, toxicity, and quality of life. An integrated economic evaluation will determine the cost per quality of life year gained using SABR (vs. SOC) and a translational component will enable identification of predictive/prognostic biomarkers of the oligometastatic state.

Condition or disease Intervention/treatment Phase
Metastatic Tumors Radiation: palliative radiotherapy Radiation: Stereotactic ablative radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study is a phase III multicentre randomized trial. Subjects 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.

Subjects will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis: histology (Group 1: prostate, breast, or renal; Group 2: all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 years vs >2 years).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Controlled Trial and Economic Evaluation of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer (SABR-COMET-3)
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Active Comparator: Standard of Care Treatment (Arm 1)
Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Radiation: 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. Patients in this arm should not receive stereotactic doses or radiotherapy boosts. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

Experimental: Stereotactic Arm (Arm 2)
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Radiation: Stereotactic ablative radiotherapy

Lung:

Tumors 5 cm or less surrounded by lung parenchyma 48 Gy/4#, or 54 Gy/3#, daily or every second day Within 2 cm of mediastinum or brachial plexus 60 Gy/8#, daily

Bone: Any bone 35 Gy/5#, or 24 Gy/2#, daily Brain: Stereotactic lesions (no whole brain RT) <2cm 20-24 Gy/1#, once 2-3 cm 18 Gy/1#, once Metastases only: 35Gy/5# to PTV, daily Whole brain + Mets: 35Gy to metastases, daily 20 Gy whole brain, daily Liver: 54 Gy/3#, every second day Adrenal: 40 Gy/5#, daily Lymph Node: 40 Gy/5#, daily





Primary Outcome Measures :
  1. Overall survival [ Time Frame: At approximately end of year 5 (study completion) ]
    Time from randomization to death from any cause


Secondary Outcome Measures :
  1. Side effects [ Time Frame: At 6 weeks, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5. ]
    Occurrences of grade 2 or higher adverse events

  2. Progression-free survival (PFS) [ Time Frame: At 6 weeks, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5. ]
    Time from randomization to disease progression at any site or death.

  3. Patient-reported quality of life (QoL) [ Time Frame: At baseline, 6 weeks, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5. ]
    Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire

  4. Health-related quality of life (HRQoL) questionnaire [ Time Frame: At baseline, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5. ]
    EuroQOL Group EQ-5D-5L

  5. Resource Utilization (Patient and Provider Reported) [ Time Frame: At 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5. ]
    Number of hospital admissions, ER visits, systemic or radiation therapy

  6. Correlation between candidate biomarkers of oligometastatic disease (blood- or tissue-derived) and oncologic outcomes [ Time Frame: At baseline, 3 months, and disease progression or study completion (Year 5) ]
    CTC and ctDNA Enumeration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Total number of metastases of 1-3
  • Age 18 or older
  • Willing to provide informed consent
  • ECOG score 0-2
  • Life expectancy >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
  • A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment
  • Not suitable for resection at all sites or decline surgery
  • Patient has had a CT chest, abdomen and pelvis or PET-CT within 8 weeks of enrollment, and with 12 weeks of treatment
  • Patient has had a nuclear bone scan (if no PET-CT) within 8 weeks of enrollment, and with 12 weeks of treatment
  • If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG PET scan or CT (chest, abdomen, pelvis) and bone scan within 8 weeks of enrollment, and with 12 weeks of treatment
  • If colorectal primary with rising CEA, but equivocal imaging, patient has had an FDG PET scan within 8 weeks of enrollment, and with 12 weeks of treatment
  • Patient has had CT or MRI brain imaging if primary has a propensity for CNS metastasis within 8 weeks of enrollment, and with 12 weeks of treatment
  • Patient is judged able to:
  • Maintain a stable position during therapy
  • Tolerate immobilization device(s) that may be required to deliver SABR safely
  • Negative pregnancy test for Women of Child-Bearing potential (WOCB) within 4 weeks of RT start date
  • Complete Blood Count (CBC)
  • Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study, using REDCap and therefore has provided their email address on the informed consent

Exclusion Criteria:

  • Previous SABR to the lesion(s)
  • Lesion in femoral bone requiring surgical fixation
  • No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 2 weeks prior to radiation, lasting until 1 week after the last fraction for patients randomized to SABR.
  • 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.
  • 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 conventional radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with one of the study PIs.
  • Malignant pleural effusion
  • History of poor lung function (if treating near lung)
  • History of poor liver function (if treating near liver)
  • Inability to treat all sites of disease
  • Maximum size of 6 cm for lesions outside the brain, except:

    • Bone metastases over 6 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)
    • Any brain metastasis >3 cm in size or a total volume of brain metastases greater than 30 cc.
  • Clinical or radiologic evidence of spinal cord compression, or epidural tumor within <2 mm of the spinal cord. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.
  • Dominant brain metastasis requiring surgical decompression
  • Pregnant or breast feeding 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): NCT03862911


Contacts
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Contact: Robert Olson, MD, MSc 250-645-7300 rolson2@bccancer.bc.ca
Contact: Lindsay Mathews 250-960-6511 mathews@unbc.ca

Locations
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Australia, Victoria
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Sashendra Senthi, MD    +61 3 9076 2000    S.Senthi@alfred.org.au   
Canada, British Columbia
BC Cancer Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Benjamin Mou, MD    250-712-3900    Benjamin.Mou@bccancer.bc.ca   
BC Cancer - Prince George Recruiting
Prince George, British Columbia, Canada, V2M 7E9
Contact: Robert Olson, MD MSc FRCPC    250-645-7300    rolson2@bccancer.bc.ca   
Contact: Lindsay Mathews    250-645-7300    lindsay.mathews@bccancer.bc.ca   
BC Cancer Not yet recruiting
Surrey, British Columbia, Canada
Contact: Devin Schellenberg, MD    604-930-4085    dschellenberg@bccancer.bc.ca   
BC Cancer Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Mitchell Liu, MD    604-877-6000    mliu@bccancer.bc.ca   
BC Cancer Not yet recruiting
Victoria, British Columbia, Canada
Contact: Tanya Berrang, MD    250-519-5577    TBerrang@bccancer.bc.ca   
Canada, Nova Scota
Nova Scotia Cancer Centre Not yet recruiting
Halifax, Nova Scota, Canada, B3H 1V8
Contact: Derek Wilke, MD    902-473-6000    Derek.Wilke@nshealth.ca   
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada
Contact: David Palma, MD, PhD    519-685-8600      
United Kingdom
Edinburgh Cancer Centre Not yet recruiting
Edinburgh, Scotland, United Kingdom
Contact: Iain Phillips, MD    +44 131 537 1000    iain.phillips1@nhs.net   
Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, United Kingdom
Contact: Stephen Harrow, MD, PhD         
Contact    +44-141-301-7000      
Sponsors and Collaborators
British Columbia Cancer Agency
London Regional Cancer Program, Canada
Beatson Institute for Cancer Research, Scotland
The Alfred
Beacon Hospital, Ireland
  Study Documents (Full-Text)

Documents provided by Robert Olson, British Columbia Cancer Agency:
Informed Consent Form  [PDF] February 24, 2020

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Olson, Radiation Oncologist & Department Head Radiation Oncology & Developmental Radiotherapeutics, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT03862911    
Other Study ID Numbers: SABR-COMET-3
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020

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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