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History of Changes for Study: NCT01446744
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET) (SABR-COMET)
Latest version (submitted April 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 3, 2011 None (earliest Version on record)
2 October 4, 2011 Outcome Measures and Study Status
3 October 7, 2011 Sponsor/Collaborators and Study Status
4 November 25, 2011 Recruitment Status, Study Status, Study Identification, Contacts/Locations, Outcome Measures and Oversight
5 December 21, 2011 Sponsor/Collaborators, Study Status and Eligibility
6 February 12, 2013 Contacts/Locations and Study Status
7 April 16, 2013 Study Status and Contacts/Locations
8 September 24, 2013 Study Status and Contacts/Locations
9 May 8, 2014 Study Status
10 October 14, 2014 Contacts/Locations, Study Status, Conditions and Study Description
11 November 25, 2014 Study Status and Contacts/Locations
12 February 17, 2015 Study Status and Contacts/Locations
13 March 16, 2015 Study Status and Contacts/Locations
14 September 28, 2015 Contacts/Locations and Study Status
15 October 18, 2015 Study Status and Contacts/Locations
16 May 26, 2016 Study Status
17 September 6, 2016 Recruitment Status, Contacts/Locations, Study Status and Study Design
18 January 23, 2018 Study Status
19 August 19, 2019 Study Status
20 February 24, 2021 Study Status
21 April 5, 2022 Study Status and Outcome Measures
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Study NCT01446744
Submitted Date:  October 3, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: SABR-COMET
Brief Title: Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET) (SABR-COMET)
Official Title: Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
Secondary IDs: 11-030 [OCREB]
Open or close this module Study Status
Record Verification: October 2011
Overall Status: Not yet recruiting
Study Start: November 2011
Primary Completion: November 2020 [Anticipated]
Study Completion:
First Submitted: September 29, 2011
First Submitted that
Met QC Criteria:
October 3, 2011
First Posted: October 5, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 3, 2011
Last Update Posted: October 5, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: David Palma
Responsible Party: Sponsor-Investigator
Investigator: David Palma
Official Title: Principal Investigator
Affiliation: Lawson Health Research Institute
Collaborators: Ontario Institute for Clinical Research
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.
Detailed Description:
Open or close this module Conditions
Conditions: Oligometastatic Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 99 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Standard arm
Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Radiation: palliative radiotherapy

Investigators should follow the principles of palliative radiotherapy as per the individual institution. Treatment recommendations are as follows:

Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions

Lung: Palliative radiotherapy as per 2011 consensus guidelines.15 i.e. 8 Gy in 1 fraction, 20 Gy in 5 fractions, 30 Gy in 10 fractions

Bone: Palliative radiotherapy as per 2011 consensus guidelines.16 i.e. 8 Gy in 1 fraction (most common), 20 Gy in 5 fractions, 30 Gy in 10 fractions

Liver: 20 Gy in 5 fractions if standard institutional practice

Experimental: Stereotactic arm
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Radiation: Stereotactic ablative radiotherapy
Total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival
[ Time Frame: At approximately end of year 4 (study completion) ]

Secondary Outcome Measures:
1. Quality of life
[ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]

2. Toxicity
[ Time Frame: Annually ]

3. Progression-free survival
[ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]

4. Lesional control rate
[ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]

5. Number of cycles of further chemotherapy/systemic therapy
[ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age 18 or older
  • Willing to provide informed consent
  • Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
  • ECOG performance status 0-1
  • Controlled primary tumor

    a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site

  • All sites of disease can be safely treated based on criteria below
  • Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
  • Life expectancy >6 months
  • Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
  • Prior chemotherapy allowed but no systemic therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction
  • Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):

    a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment

    a. If that previously treated metastasis is NOT controlled on imaging:

    1. If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
    2. If the previous treatment was radiotherapy or RFA, the patient is ineligible.
  • Patient presented at multidisciplinary tumor board or quality-assurance rounds.

Exclusion Criteria:

  • Serious medical comorbidities precluding radiotherapy
  • Bone metastasis in a femoral bone
  • Patients with hormone-sensitive disease (e.g. prostate cancer or estrogen-receptor breast cancer) who still have an standard hormonal treatment available or are receiving hormone treatment
  • Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
  • Prior radiotherapy to a site requiring treatment
  • Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
  • Malignant pleural effusion
  • Inability to treat all sites of active disease
  • Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on Magnetic Resonance Imaging (MRI).
  • Dominant brain metastasis requiring surgical decompression
  • Pregnant or lactating women
Open or close this module Contacts/Locations
Central Contact Person: David Palma, MD, PhD
Telephone: 519-685-8650
Email: David.Palma@lhsc.on.ca
Study Officials: David Palma, MD, PhD
Principal Investigator
London Regional Cancer Program of the Lawson Health Research Institute
Suresh Senan, MRCP, FRCR, PhD
Principal Investigator
Amsterdam UMC, location VUmc
Locations: Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
Contact:Contact: David Palma, MD 519-685-8650 David.Palma@lhsc.on.ca
Contact:Principal Investigator: David Palma, MD, PhD
Ottawa Cancer Centre
Ottawa, Ontario, Canada
Contact:Contact: Jason Pantarotto, MD
Contact:Principal Investigator: Jason Pantarotto, MD
Netherlands
VU University Amsterdam (VUmc)
Amsterdam, Netherlands
Contact:Contact: Suresh Senan, MRCP
Contact:Principal Investigator: Suresh Senan, MRCP, FRCR, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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