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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

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ClinicalTrials.gov Identifier: NCT03721341
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : February 26, 2019
Sponsor:
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

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

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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
Active Comparator: Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
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.

Experimental: Stereotactic Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
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 :
  1. 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 :
  1. 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.

  2. 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.

  3. 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) ]
  4. Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire [ Time Frame: At approximately end of year 6 (study completion) ]
  5. 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) ]
  6. 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
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Contact: David Palma, MD 519-685-8650 David.Palma@lhsc.on.ca

Locations
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Canada, Ontario
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         
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
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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

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Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03721341     History of Changes
Other Study ID Numbers: SABR-COMET 10
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Hormones
Immunologic Factors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs