<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/NCT04430725</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0301</org_study_id>
    <secondary_id>NCI-2020-03474</secondary_id>
    <secondary_id>2018-0301</secondary_id>
    <nct_id>NCT04430725</nct_id>
  </id_info>
  <brief_title>Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study</brief_title>
  <official_title>Ablation of Lung Lesions Using Microwave Energy (ALLUME)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the outcomes and safety of two standard treatment options called&#xD;
      microwave ablation and surgical wedge resection in patients with non-small cell lung cancer,&#xD;
      sarcoma and colorectal cancer that has spread to other parts of the body (metastatic).&#xD;
      Microwave ablation is designed to kill tumor cells by heating the tumor until the tumor cells&#xD;
      die. A wedge resection is a procedure that involves the surgical removal of a small,&#xD;
      wedge-shaped piece of lung tissue to remove a small tumor or to diagnose lung cancer.&#xD;
      Comparing these two treatment options may help researchers learn which method works better&#xD;
      for the treatment of non-small cell lung cancer, metastatic sarcoma, and metastatic&#xD;
      colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Estimate the 2-year local recurrence rate for microwave ablation within a basket.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate whether microwave ablation offers treatment benefit for safety when compared to&#xD;
      wedge resection using a contemporaneous database consisting of a commensurate surgical&#xD;
      patient population.&#xD;
&#xD;
      II. Evaluate whether microwave ablation offers treatment benefit for efficacy when compared&#xD;
      to wedge resection using a contemporaneous database consisting of a commensurate surgical&#xD;
      patient population.&#xD;
&#xD;
      III. Evaluate whether microwave ablation offers treatment benefit for changes in patient&#xD;
      reported outcomes when compared to wedge resection using a contemporaneous database&#xD;
      consisting of a commensurate surgical patient population.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo standard care microwave ablation or wedge resection followed by&#xD;
      contrast-enhanced computed tomography (CT) imaging at 1, 6, 12, 18 and 24 months. Patients&#xD;
      also complete questionnaires over 10-15 minutes at baseline up to 9 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 7, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to local recurrence per treated nodule</measure>
    <time_frame>Up to 2 years post-ablation</time_frame>
    <description>Will be measured from the first date of treatment and characterized according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and/or biopsy. The local recurrence of each subtype will be adjusted according to the method proposed by Fine and Gray. Will evaluate each basket individually and allow patients to contribute multiple nodules. Therefore, the Bayesian piecewise constant frailty model will be used to account for interdependence in the failure duration of nodules arising from the same patient. Additional posterior summaries will be reported, such as median failure duration. Additionally, will report plots of the full time-to-failure distribution with pointwise 95% Bayesian credible intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant adverse events</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>The occurrence of significant adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) published by the National Institutes of Health. Grade III or above adverse events within the following categories: cardiac disorders, general disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, and respiratory, thoracic and mediastinal disorders. 30-day mortality will also be recorded. Patient adverse events will be tabulated by symptom grade and categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to local recurrence per patient</measure>
    <time_frame>Up to 2 years post-ablation</time_frame>
    <description>Contrast-enhanced CT imaging will be used to monitor for local recurrence. Local recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional and distance recurrence</measure>
    <time_frame>Up to 2 years post-ablation</time_frame>
    <description>Regional and distant recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival per patient</measure>
    <time_frame>Up to 2 years post-ablation</time_frame>
    <description>Frequentist interference will use the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patient reported outcomes per patient</measure>
    <time_frame>Up to 9 months after enrollment</time_frame>
    <description>Will be reported as time to symptom recovering using MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) questionnaires. Frequentist interference will use the Kaplan-Meier method.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Lung Non-Small Cell Carcinoma</condition>
  <condition>Metastatic Colorectal Carcinoma</condition>
  <condition>Metastatic Sarcoma</condition>
  <condition>Stage I Lung Cancer AJCC v8</condition>
  <condition>Stage IA1 Lung Cancer AJCC v8</condition>
  <condition>Stage IA2 Lung Cancer AJCC v8</condition>
  <condition>Stage IA3 Lung Cancer AJCC v8</condition>
  <condition>Stage IB Lung Cancer AJCC v8</condition>
  <condition>Stage II Lung Cancer AJCC v8</condition>
  <condition>Stage IIA Lung Cancer AJCC v8</condition>
  <condition>Stage IIB Lung Cancer AJCC v8</condition>
  <condition>Stage III Lung Cancer AJCC v8</condition>
  <condition>Stage IIIA Lung Cancer AJCC v8</condition>
  <condition>Stage IIIB Lung Cancer AJCC v8</condition>
  <condition>Stage IIIC Lung Cancer AJCC v8</condition>
  <condition>Stage IV Colorectal Cancer AJCC v8</condition>
  <condition>Stage IV Lung Cancer AJCC v8</condition>
  <condition>Stage IVA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVA Lung Cancer AJCC v8</condition>
  <condition>Stage IVB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVB Lung Cancer AJCC v8</condition>
  <condition>Stage IVC Colorectal Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Observational (microwave ablation, wedge excision, CT)</arm_group_label>
    <description>Patients undergo standard care microwave ablation or wedge resection followed by contrast-enhanced CT imaging at 1, 6, 12, 18 and 24 months. Patients also complete questionnaires over 10-15 minutes at baseline up to 9 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography with Contrast</intervention_name>
    <description>Undergo contrast-enhanced CT</description>
    <arm_group_label>Observational (microwave ablation, wedge excision, CT)</arm_group_label>
    <other_name>Contrast Enhanced Computed Tomography</other_name>
    <other_name>CONTRAST ENHANCED CT SCAN</other_name>
    <other_name>Contrast-enhanced Computed Tomography</other_name>
    <other_name>CT Scan With Contrast</other_name>
    <other_name>CT with Contrast</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microwave Ablation</intervention_name>
    <description>Undergo microwave ablation</description>
    <arm_group_label>Observational (microwave ablation, wedge excision, CT)</arm_group_label>
    <other_name>Ablation, Microwave</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (microwave ablation, wedge excision, CT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Wedge Excision</intervention_name>
    <description>Undergo wedge resection</description>
    <arm_group_label>Observational (microwave ablation, wedge excision, CT)</arm_group_label>
    <other_name>Wedge Resection</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with non-small cell lung cancer, metastatic sarcoma, or metastatic colorectal&#xD;
        cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has a lung lesion(s) that is either biopsy-proven cancer or shows sequential&#xD;
             growth on CT imaging with clinical suspicion for non-small cell lung cancer&#xD;
             (NSCLC)-stage I; NSCLC-stage &gt; 1; metastatic sarcoma; or metastatic colorectal (CRC)&#xD;
             cancer&#xD;
&#xD;
          -  3 cm or less tumor size&#xD;
&#xD;
          -  Other sites for cancer are either controlled or there are plans for control&#xD;
&#xD;
          -  Expected margin at least 1 cm from critical structures, allowing for protective&#xD;
             strategies such as induction of therapeutic pneumothorax. Critical structures include&#xD;
             the trachea, main bronchi, esophagus, aorta, aortic arch branches, superior vena cava&#xD;
             (SVC), main, right or left pulmonary artery, or heart.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is considered high risk for ablation due to major comorbid medical conditions&#xD;
&#xD;
          -  Patient is pregnant or breast feeding&#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>Wayne L Hofstetter</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wayne L Hofstetter</last_name>
    <phone>713-563-0136</phone>
    <email>whofstetter@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wayne L. Hofstetter</last_name>
      <phone>713-563-0136</phone>
    </contact>
    <investigator>
      <last_name>Wayne L. Hofstetter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- 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/NCT04430725
org study id: 2018-0301
secondary id: NCI-2020-03474
secondary id: 2018-0301
nct id: NCT04430725
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study compares the outcomes and safety of two standard treatment options called
      microwave ablation and surgical wedge resection in patients with non-small cell lung cancer,
      sarcoma and colorectal cancer that has spread to other parts of the body (metastatic).
      Microwave ablation is designed to kill tumor cells by heating the tumor until the tumor cells
      die. A wedge resection is a procedure that involves the surgical removal of a small,
      wedge-shaped piece of lung tissue to remove a small tumor or to diagnose lung cancer.
      Comparing these two treatment options may help researchers learn which method works better
      for the treatment of non-small cell lung cancer, metastatic sarcoma, and metastatic
      colorectal cancer.
PRIMARY OBJECTIVE:

      I. Estimate the 2-year local recurrence rate for microwave ablation within a basket.

      SECONDARY OBJECTIVES:

      I. Evaluate whether microwave ablation offers treatment benefit for safety when compared to
      wedge resection using a contemporaneous database consisting of a commensurate surgical
      patient population.

      II. Evaluate whether microwave ablation offers treatment benefit for efficacy when compared
      to wedge resection using a contemporaneous database consisting of a commensurate surgical
      patient population.

      III. Evaluate whether microwave ablation offers treatment benefit for changes in patient
      reported outcomes when compared to wedge resection using a contemporaneous database
      consisting of a commensurate surgical patient population.

      OUTLINE:

      Patients undergo standard care microwave ablation or wedge resection followed by
      contrast-enhanced computed tomography (CT) imaging at 1, 6, 12, 18 and 24 months. Patients
      also complete questionnaires over 10-15 minutes at baseline up to 9 months.
observational model: Cohort
time perspective: Prospective
measure: Time to local recurrence per treated nodule
time frame: Up to 2 years post-ablation
description: Will be measured from the first date of treatment and characterized according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and/or biopsy. The local recurrence of each subtype will be adjusted according to the method proposed by Fine and Gray. Will evaluate each basket individually and allow patients to contribute multiple nodules. Therefore, the Bayesian piecewise constant frailty model will be used to account for interdependence in the failure duration of nodules arising from the same patient. Additional posterior summaries will be reported, such as median failure duration. Additionally, will report plots of the full time-to-failure distribution with pointwise 95% Bayesian credible intervals.
measure: Incidence of clinically significant adverse events
time frame: Up to 30 days
description: The occurrence of significant adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) published by the National Institutes of Health. Grade III or above adverse events within the following categories: cardiac disorders, general disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, and respiratory, thoracic and mediastinal disorders. 30-day mortality will also be recorded. Patient adverse events will be tabulated by symptom grade and categories.
measure: Time to local recurrence per patient
time frame: Up to 2 years post-ablation
description: Contrast-enhanced CT imaging will be used to monitor for local recurrence. Local recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method.
measure: Regional and distance recurrence
time frame: Up to 2 years post-ablation
description: Regional and distant recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method.
measure: Overall survival per patient
time frame: Up to 2 years post-ablation
description: Frequentist interference will use the Kaplan-Meier method.
measure: Changes in patient reported outcomes per patient
time frame: Up to 9 months after enrollment
description: Will be reported as time to symptom recovering using MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) questionnaires. Frequentist interference will use the Kaplan-Meier method.
arm group label: Observational (microwave ablation, wedge excision, CT)
description: Patients undergo standard care microwave ablation or wedge resection followed by contrast-enhanced CT imaging at 1, 6, 12, 18 and 24 months. Patients also complete questionnaires over 10-15 minutes at baseline up to 9 months.
intervention type: Procedure
intervention name: Computed Tomography with Contrast
description: Undergo contrast-enhanced CT
arm group label: Observational (microwave ablation, wedge excision, CT)
other name: Contrast Enhanced Computed Tomography
other name: CONTRAST ENHANCED CT SCAN
other name: Contrast-enhanced Computed Tomography
other name: CT Scan With Contrast
other name: CT with Contrast
intervention type: Procedure
intervention name: Microwave Ablation
description: Undergo microwave ablation
arm group label: Observational (microwave ablation, wedge excision, CT)
other name: Ablation, Microwave
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Observational (microwave ablation, wedge excision, CT)
intervention type: Procedure
intervention name: Wedge Excision
description: Undergo wedge resection
arm group label: Observational (microwave ablation, wedge excision, CT)
other name: Wedge Resection
Tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wayne L Hofstetter
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Wayne L Hofstetter
phone: 713-563-0136
email: whofstetter@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Lung Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Sarcoma
mesh term: Carcinoma, Non-Small-Cell Lung