Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 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)
Estimated Study Start Date : April 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# 12, or 54 Gy/3# 18, every second day Within 2 cm of mediastinum or brachial plexus 60 Gy/8# 7.5, daily Bone: Any bone 35 Gy/5# 7, or 24 Gy/2# 12, daily Brain: Stereotactic lesions (no whole brain RT) <2cm 24 Gy/1# 24, once 2-3 cm 18 Gy/1# 18, once 3-4cm 15 Gy/1# 15, once

If whole brain treated, then simultaneous boost to each lesion:

35Gy/5# to metastases 7 Gy to PTV, daily 20 Gy/5# whole brain (optional) 4 Gy WBRT, daily Liver: 54 Gy/3# 18, every second day Adrenal: 60 Gy/8# 7.5, daily Lymph Node: 40 Gy/5# 8, 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 approximately end of years 1, 2, 3, 4, and 5 (study completion) ]
    Occurrences of grade 2 or higher adverse events

  2. Progression-free survival (PFS) [ Time Frame: At approximately end of years 1, 2, 3, 4, and 5 (study completion) ]
    Time from randomization to disease progression at any site or death.

  3. Patient-reported quality of life (QoL) [ Time Frame: At approximately end of years 1, 2, 3, 4, and 5 (study completion) ]
    Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire

  4. Health-related quality of life (HRQoL) questionnaire [ Time Frame: At approximately end of years 1, 2, 3, 4, and 5 (study completion) ]
    EuroQOL Group EQ-5D-5L

  5. Correlation between candidate biomarkers of oligometastatic disease (blood- or tissue-derived) and oncologic outcomes [ Time Frame: At approximately end of years 1, 2, 3, 4, and 5 (study completion) ]
    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.


Layout table for eligibility information
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
  • 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)
  • Total number of metastases of 1-3

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.
  • 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
  • Inability to treat all sites of disease
  • Maximum size of 6 cm for lesions outside the brain, except:

    • Bone metastases over 5 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
Layout table for location contacts
Contact: Robert Olson, MD, MSc 250-645-7300 rolson2@bccancer.bc.ca
Contact: Lindsay Mathews 250-960-6511 mathews@unbc.ca

Locations
Layout table for location information
Canada, British Columbia
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    250-645-7300    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, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada
Contact: David Palma, MD, PhD    519-685-8600      
United Kingdom
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

Publications:

Layout table for additonal information
Responsible Party: Robert Olson, Radiation Oncologist & Department Head Radiation Oncology & Developmental Radiotherapeutics, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT03862911     History of Changes
Other Study ID Numbers: COMET-3
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes