<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03295916</url>
  </required_header>
  <id_info>
    <org_study_id>3764</org_study_id>
    <nct_id>NCT03295916</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiotherapy for Patients With Breast Cancer Oligometastasis</brief_title>
  <acronym>STOMP</acronym>
  <official_title>Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastasis in Breast Cancer Patients (STOMP): A Prospective Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Juravinski Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Toronto Sunnybrook Regional Cancer Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Juravinski Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate feasibility to treat metachronous multi-site breast&#xD;
      cancer oligometastasis with stereotactic body radiotherapy (SBRT) in patients on systemic&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who present with or develop metastatic breast cancer after initial therapy are&#xD;
      typically considered incurable. Treatments offered are to relieve symptoms and are palliative&#xD;
      in intent, including chemotherapy, hormonal therapy, biologics (e.g. trastuzumab for Her2&#xD;
      positive disease), bisphosphonates (for bone protection), palliative radiotherapy for symptom&#xD;
      relief, and supportive care. Prognosis is guarded, with median OS estimated at 2-3 years, and&#xD;
      progression free survival (PFS) approximately 9-12 months.&#xD;
&#xD;
      Based on research observing the natural history of breast cancer, it was discovered that some&#xD;
      cancers have a predilection for spread to a limited number of sites and remain in these sites&#xD;
      for a number of months before acquiring widespread malignant potential. This is defined as&#xD;
      the oligometastatic state, and patients with up to five sites of disease are said to have&#xD;
      oligometastatic (OM) cancer. A number of studies of systemic therapy in metastatic breast&#xD;
      cancer have reported that patients with OM disease have a better prognosis compared to other&#xD;
      patients with more widespread disease, and in particular in patients with bone-only&#xD;
      metastastic breast cancer, outcomes may be better.&#xD;
&#xD;
      In the setting of OM disease in particular, local therapies could be considered. For example,&#xD;
      metastatectomies have been adopted into clinical practice in patients with colorectal cancer&#xD;
      liver metastases and sarcoma lung metastases with encouraging long-term outcomes. In the case&#xD;
      of metastatic breast cancer, there is less data to support a local therapy approach. Breast&#xD;
      cancer patients in particular commonly present with metastatic bone, lung and liver disease.&#xD;
      Some of these sites, for example bony or spinal disease, are not as easily amenable to&#xD;
      surgical resection, and surgery itself can cause significant morbidity. In such patients, it&#xD;
      would be desirable to consider a locally ablative therapy that is non-invasive, versatile&#xD;
      (can treat multiple sites simultaneously); generalizable to patients of various performance&#xD;
      statuses; have low rates of toxicity; and be proven to eradicate disease in treated areas.&#xD;
&#xD;
      Standard conformal radiotherapy (RT) is traditionally used for the treatment of metastatic&#xD;
      breast cancer. The main indication for RT has been with palliative intent, and relatively low&#xD;
      doses are used with the goal of symptom control. Higher RT doses given in 5-6 weeks (50-60&#xD;
      Gy/25-30 fractions) may improve local control (LC); however they are inconvenient and may be&#xD;
      associated with increased acute toxicity. Over the past 10 years, due to technical advances&#xD;
      in RT planning and delivery, the ability to precisely and safely deliver larger daily doses&#xD;
      over shorter periods of time has developed, known as stereotactic body radiotherapy (SBRT).&#xD;
      This technique is defined by the Canadian Association of Radiation Oncology as: &quot;The precise&#xD;
      delivery of highly conformal and image-guided hypo-fractionated external beam radiotherapy,&#xD;
      delivered in a single or few fraction(s), to an extra-cranial body target with doses at least&#xD;
      biologically equivalent to a radical course when given over a conventionally fractionated&#xD;
      (1.8-3.0 Gy/fraction) schedule&quot;. SBRT is a non-invasive method involving delivery of multiple&#xD;
      small radiation beams from many angles with sub-millimetre precision, targeted to eradicate&#xD;
      intracranial lesions. The goal is to use large ablative doses to achieve permanent tumour&#xD;
      control with 1-6 fractions of 5-20 Gy per fraction. Ultimately this represents a&#xD;
      philosophical shift in treating a metastatic site with locally &quot;ablative&quot; doses of radiation&#xD;
      in a safe, effective, and convenient fashion.&#xD;
&#xD;
      There is growing evidence to support the safety and efficacy of SBRT to many single organ&#xD;
      sites, and literature reviews demonstrate LC of 70-90% in OM sites at 1-2 years. A recent&#xD;
      systematic review of the literature of ablative therapies in metastatic breast cancer&#xD;
      (including SBRT) revealed significant heterogeneity in observed studies, and no clearly&#xD;
      definable subgroups that may benefit, with the exception of patients who had complete&#xD;
      ablation of their residual disease. The conclusion from this study was that further clinical&#xD;
      trials were necessary to demonstrate benefit of ablative therapies as compared to standard&#xD;
      treatment in breast OM.&#xD;
&#xD;
      Therefore, while SBRT has been used safely and effectively to treat OM evidence suggests&#xD;
      there is still a need in better characterizing the role of SBRT with respect to local&#xD;
      control, freedom from distant progression and potentially survival. The investigators believe&#xD;
      that patients with metastatic breast cancer are likely to benefit from SBRT for a number of&#xD;
      reasons: 1) a significant portion of patients develop OM disease; 2) the most common breast&#xD;
      OM sites including bone, liver and lung are amenable to SBRT; 3) with improvements in&#xD;
      systemic therapy, there is a high probability that microscopic (non-clinically evident)&#xD;
      metastatic disease will be controlled, so that additional local therapy may be synergistic&#xD;
      and improve local control and symptom development in the future. Notwithstanding these&#xD;
      factors, SBRT to bony and other sites is rarely used in metastatic breast cancer patients in&#xD;
      Canada for several reasons: there is a gap in knowledge regarding the potential role of SBRT&#xD;
      in these patients, a current pattern of referrals and triage for more traditional palliative&#xD;
      treatments, and lack of standardized protocols to treat, assess response and follow these&#xD;
      patients. The investigators propose a feasibility study, which addresses these issues in&#xD;
      patients with OM breast cancer to bony and visceral sites, which may provide the background&#xD;
      foundation for future research and patient care. The study aims to address not only&#xD;
      feasibility, but local control, survival, toxicity, and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical feasibility of planning SBRT to multiple sites</measure>
    <time_frame>Two weeks from consent</time_frame>
    <description>Successful planning and delivery of SBRT to multiple sites, defined by covering 95% of target volume with 95% of prescribed dose, while keeping within established normal tissue constraints for 2, 3, 5 fraction SBRT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity: Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0</measure>
    <time_frame>One week, 3,6, 12 months from SBRT treatment</time_frame>
    <description>Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of patient accrual: Successful accrual of 30 patients to study</measure>
    <time_frame>At 12 months from study initiation</time_frame>
    <description>Successful accrual of 30 patients to study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Control: CT scan or MRI as assessed by RECIST criteria 1.1</measure>
    <time_frame>3, 6, 12 months from SBRT treatment</time_frame>
    <description>CT scan or MRI as assessed by RECIST criteria 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>3, 6, 12 months from SBRT treatment</time_frame>
    <description>CT scan or MRI as assessed by RECIST criteria 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>3, 6 12 months from SBRT treatment</time_frame>
    <description>OS in months censored at last follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life defined by EORTC Quality of Life Questionnaire core-30</measure>
    <time_frame>One week, 3, 6, 12 months from SBRT treatment</time_frame>
    <description>Patient-reported, defined by EORTC Quality of Life Questionnaire core-30</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Systemic therapy plus SBRT to OM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stereotactic Body Radiotherapy (SBRT) up to 5 OM sites</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiotherapy</intervention_name>
    <description>Five fraction SBRT (or two fraction in case of spine) to any sites of breast cancer oligometastasis using robotic radio surgery or linear accelerator based SBRT</description>
    <arm_group_label>Systemic therapy plus SBRT to OM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of newly metastatic breast cancer with a disease-free interval of at least&#xD;
             six months from initial completion of primary breast cancer (stage I-III) treatment&#xD;
             (including net-adjuvant or adjuvant chemotherapy, but excluding hormonal or targeted&#xD;
             therapies).&#xD;
&#xD;
             Adequate definitive primary treatment is required, including partial or complete&#xD;
             mastectomy, standard partial breast, whole breast or loco-regional radiotherapy, with&#xD;
             or without hormonal therapy or chemotherapy. Note patients must be offered systemic&#xD;
             therapy prior to radiotherapy, if deemed fit for treatment. Systemic therapy&#xD;
             (including chemotherapy, hormonal therapy, or targeted therapy may have been initiated&#xD;
             within the previous 12 months, or commence following SBRT. Alternatively patients may&#xD;
             develop breast OM while on any adjuvant hormonal therapy provided at least six months&#xD;
             have passed since definitive local treatment or chemotherapy;&#xD;
&#xD;
          2. No more than 12 months may have passed since diagnosis of OM disease;&#xD;
&#xD;
          3. Total burden of disease limited to 5 metastatic sites or less, and the size of each&#xD;
             metastatic lesion must be less than 5 centimeters;&#xD;
&#xD;
          4. All lesions amenable to SBRT (lesions may overlap if treatable at discretion of&#xD;
             Radiation Oncologist).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous radiotherapy to same site or vicinity preventing definitive SBRT (eg. within&#xD;
             5 cm);&#xD;
&#xD;
          2. Unacceptable fracture risk according to clinician judgement for bone lesions;&#xD;
&#xD;
          3. Brain metastasis, spinal cord compression, superior vena cava obstruction;&#xD;
&#xD;
          4. Bone lesions inside the femoral head/neck;&#xD;
&#xD;
          5. Patients refusing or deemed ineligible for systemic (chemotherapy, hormonal therapy or&#xD;
             targeted therapy);&#xD;
&#xD;
          6. History of major radiosensitivity syndrome or contraindications to radiotherapy;&#xD;
&#xD;
          7. Second invasive malignancy within the past 3 years (excluding non-melanomatous skin&#xD;
             cancer);&#xD;
&#xD;
          8. Inability to lie supine for 60 minutes of treatment;&#xD;
&#xD;
          9. Currently pregnant or lactating;&#xD;
&#xD;
         10. Psychiatric or addictive disorders precluding informed consent or adherence to&#xD;
             protocol;&#xD;
&#xD;
         11. Geographic inaccessibility for follow-up;&#xD;
&#xD;
         12. Performance status Eastern Cooperative Oncology Group 3 or worse;&#xD;
&#xD;
         13. Inadequate organ function: complete blood count, liver function tests including&#xD;
             albumin, bilirubin and International nominalized ratio (INR) (for liver SBRT);&#xD;
&#xD;
         14. Less than 18 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anand Swaminath, MD,FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elysia Donovan, MD,FRCPC</last_name>
    <phone>9053879495</phone>
    <email>donovane@hhsc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elysia K Donovan, MD, FRCPC</last_name>
      <phone>905-387-9495</phone>
      <email>donovane@hhsc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Anand Swaminath, MD, FRCPC</last_name>
      <phone>905-387-9495</phone>
      <email>swaminath@hhsc.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
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  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Juravinski Cancer Center</investigator_affiliation>
    <investigator_full_name>Elysia Donovan</investigator_full_name>
    <investigator_title>Local Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>De-identified patient data may be shared with other participating centres (Odette Sunnybrook Cancer Centre)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295916
org study id: 3764
nct id: NCT03295916
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate feasibility to treat metachronous multi-site breast
      cancer oligometastasis with stereotactic body radiotherapy (SBRT) in patients on systemic
      therapy.
Patients who present with or develop metastatic breast cancer after initial therapy are
      typically considered incurable. Treatments offered are to relieve symptoms and are palliative
      in intent, including chemotherapy, hormonal therapy, biologics (e.g. trastuzumab for Her2
      positive disease), bisphosphonates (for bone protection), palliative radiotherapy for symptom
      relief, and supportive care. Prognosis is guarded, with median OS estimated at 2-3 years, and
      progression free survival (PFS) approximately 9-12 months.

      Based on research observing the natural history of breast cancer, it was discovered that some
      cancers have a predilection for spread to a limited number of sites and remain in these sites
      for a number of months before acquiring widespread malignant potential. This is defined as
      the oligometastatic state, and patients with up to five sites of disease are said to have
      oligometastatic (OM) cancer. A number of studies of systemic therapy in metastatic breast
      cancer have reported that patients with OM disease have a better prognosis compared to other
      patients with more widespread disease, and in particular in patients with bone-only
      metastastic breast cancer, outcomes may be better.

      In the setting of OM disease in particular, local therapies could be considered. For example,
      metastatectomies have been adopted into clinical practice in patients with colorectal cancer
      liver metastases and sarcoma lung metastases with encouraging long-term outcomes. In the case
      of metastatic breast cancer, there is less data to support a local therapy approach. Breast
      cancer patients in particular commonly present with metastatic bone, lung and liver disease.
      Some of these sites, for example bony or spinal disease, are not as easily amenable to
      surgical resection, and surgery itself can cause significant morbidity. In such patients, it
      would be desirable to consider a locally ablative therapy that is non-invasive, versatile
      (can treat multiple sites simultaneously); generalizable to patients of various performance
      statuses; have low rates of toxicity; and be proven to eradicate disease in treated areas.

      Standard conformal radiotherapy (RT) is traditionally used for the treatment of metastatic
      breast cancer. The main indication for RT has been with palliative intent, and relatively low
      doses are used with the goal of symptom control. Higher RT doses given in 5-6 weeks (50-60
      Gy/25-30 fractions) may improve local control (LC); however they are inconvenient and may be
      associated with increased acute toxicity. Over the past 10 years, due to technical advances
      in RT planning and delivery, the ability to precisely and safely deliver larger daily doses
      over shorter periods of time has developed, known as stereotactic body radiotherapy (SBRT).
      This technique is defined by the Canadian Association of Radiation Oncology as: "The precise
      delivery of highly conformal and image-guided hypo-fractionated external beam radiotherapy,
      delivered in a single or few fraction(s), to an extra-cranial body target with doses at least
      biologically equivalent to a radical course when given over a conventionally fractionated
      (1.8-3.0 Gy/fraction) schedule". SBRT is a non-invasive method involving delivery of multiple
      small radiation beams from many angles with sub-millimetre precision, targeted to eradicate
      intracranial lesions. The goal is to use large ablative doses to achieve permanent tumour
      control with 1-6 fractions of 5-20 Gy per fraction. Ultimately this represents a
      philosophical shift in treating a metastatic site with locally "ablative" doses of radiation
      in a safe, effective, and convenient fashion.

      There is growing evidence to support the safety and efficacy of SBRT to many single organ
      sites, and literature reviews demonstrate LC of 70-90% in OM sites at 1-2 years. A recent
      systematic review of the literature of ablative therapies in metastatic breast cancer
      (including SBRT) revealed significant heterogeneity in observed studies, and no clearly
      definable subgroups that may benefit, with the exception of patients who had complete
      ablation of their residual disease. The conclusion from this study was that further clinical
      trials were necessary to demonstrate benefit of ablative therapies as compared to standard
      treatment in breast OM.

      Therefore, while SBRT has been used safely and effectively to treat OM evidence suggests
      there is still a need in better characterizing the role of SBRT with respect to local
      control, freedom from distant progression and potentially survival. The investigators believe
      that patients with metastatic breast cancer are likely to benefit from SBRT for a number of
      reasons: 1) a significant portion of patients develop OM disease; 2) the most common breast
      OM sites including bone, liver and lung are amenable to SBRT; 3) with improvements in
      systemic therapy, there is a high probability that microscopic (non-clinically evident)
      metastatic disease will be controlled, so that additional local therapy may be synergistic
      and improve local control and symptom development in the future. Notwithstanding these
      factors, SBRT to bony and other sites is rarely used in metastatic breast cancer patients in
      Canada for several reasons: there is a gap in knowledge regarding the potential role of SBRT
      in these patients, a current pattern of referrals and triage for more traditional palliative
      treatments, and lack of standardized protocols to treat, assess response and follow these
      patients. The investigators propose a feasibility study, which addresses these issues in
      patients with OM breast cancer to bony and visceral sites, which may provide the background
      foundation for future research and patient care. The study aims to address not only
      feasibility, but local control, survival, toxicity, and quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical feasibility of planning SBRT to multiple sites
time frame: Two weeks from consent
description: Successful planning and delivery of SBRT to multiple sites, defined by covering 95% of target volume with 95% of prescribed dose, while keeping within established normal tissue constraints for 2, 3, 5 fraction SBRT.
measure: Toxicity: Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0
time frame: One week, 3,6, 12 months from SBRT treatment
description: Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0
measure: Feasibility of patient accrual: Successful accrual of 30 patients to study
time frame: At 12 months from study initiation
description: Successful accrual of 30 patients to study
measure: Local Control: CT scan or MRI as assessed by RECIST criteria 1.1
time frame: 3, 6, 12 months from SBRT treatment
description: CT scan or MRI as assessed by RECIST criteria 1.1
measure: Progression Free Survival (PFS)
time frame: 3, 6, 12 months from SBRT treatment
description: CT scan or MRI as assessed by RECIST criteria 1.1
measure: Overall Survival (OS)
time frame: 3, 6 12 months from SBRT treatment
description: OS in months censored at last follow up
measure: Quality of Life defined by EORTC Quality of Life Questionnaire core-30
time frame: One week, 3, 6, 12 months from SBRT treatment
description: Patient-reported, defined by EORTC Quality of Life Questionnaire core-30
arm group label: Systemic therapy plus SBRT to OM
arm group type: Experimental
description: Stereotactic Body Radiotherapy (SBRT) up to 5 OM sites
intervention type: Radiation
intervention name: Stereotactic Body Radiotherapy
description: Five fraction SBRT (or two fraction in case of spine) to any sites of breast cancer oligometastasis using robotic radio surgery or linear accelerator based SBRT
arm group label: Systemic therapy plus SBRT to OM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anand Swaminath, MD,FRCPC
role: Principal Investigator
affiliation: McMaster University
last name: Elysia Donovan, MD,FRCPC
phone: 9053879495
email: donovane@hhsc.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
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responsible party type: Principal Investigator
investigator affiliation: Juravinski Cancer Center
investigator full name: Elysia Donovan
investigator title: Local Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: Undecided
ipd description: De-identified patient data may be shared with other participating centres (Odette Sunnybrook Cancer Centre)