xml: <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/NCT05985148</url>
    </required_header>
    <id_info>
      <org_study_id>22-176</org_study_id>
      <nct_id>NCT05985148</nct_id>
    </id_info>
    <brief_title>A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall</brief_title>
    <official_title>A Phase I Dose Escalation Trial for Treatment of Chronic Thoracoabdominal Wall Pain Through Ablation of the Dorsal Spinal Nerve Using Single-Fraction Stereotactic Radiosurgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Varian Medical Systems</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a&#xD;
        safe, practical (feasible), and effective treatment for people with chronic TAWP. The&#xD;
        researchers will test different doses of SRS to find the highest dose that causes few or mild&#xD;
        side effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2028</primary_completion_date>
    <phase>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>
      <intervention_model_description>This is a phase I clinical trial investigating the use of frameless single-fraction stereotactic radiosurgery (SRS) to treat chronic unilateral thoracoabdominal wall pain limited in distribution to three or fewer spinal levels from T3-T11 through ablation of the dorsal spinal nerve root.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>can be escalated from 70 Gy to 90 Gy without excessive DLTs</measure>
      <time_frame>2 years</time_frame>
      <description>DLT's CTCAE grade ≥ 3 toxicity. Acute and late toxicity will be assessed by investigators and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Toxicities that cannot be graded using the Common Toxicity Criteria will be graded as 1 (mildly symptomatic), 2 (moderately symptomatic but not interfering significantly with function), 3 (causing significant interference with function), or 4 (life-threatening).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Thoracoabdominal Wall Pain</condition>
    <condition>Secondary to Parietal Pleura or Parietal Peritoneum Disease</condition>
    <arm_group>
      <arm_group_label>Single-fraction stereotactic radiosurgery (SRS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be treated with single-fraction radiation therapy at three dose levels:&#xD;
  70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Single-fraction stereotactic radiosurgery (SRS)</intervention_name>
      <description>Patients will be treated with single-fraction radiation therapy at three dose levels:&#xD;
  70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.</description>
      <arm_group_label>Single-fraction stereotactic radiosurgery (SRS)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall&#xD;
               pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by diagnostic&#xD;
               paravertebral nerve block or TENS (if results of the paravertebral nerve block are&#xD;
               inconclusive) performed by an attending anesthesiologist specializing in pain&#xD;
               management prior to study enrollment.&#xD;
  &#xD;
            -  Patients must have TAWP that is inadequately relieved by a trial of conventional&#xD;
               pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment with&#xD;
               conventional pharmacologic therapy for analgesia) as determined by an attending&#xD;
               physician specializing in pain management.&#xD;
  &#xD;
            -  KPS ≥ 60%&#xD;
  &#xD;
            -  Age ≥ 18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a life expectancy of &lt; 6 months as predicted by the Adult Comorbidity&#xD;
               Index (ACE-27, see Appendix 1)&#xD;
  &#xD;
            -  Patients with active autoimmune connective tissue disease&#xD;
  &#xD;
            -  Patients with bilateral TAWP&#xD;
  &#xD;
            -  Patients with preexisting pneumothorax&#xD;
  &#xD;
            -  Patients with preexisting excessive pleural effusion (extending &gt; 3 vertebral levels)&#xD;
  &#xD;
            -  Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS&#xD;
  &#xD;
            -  Unable to undergo a diagnostic paravertebral nerve block&#xD;
  &#xD;
            -  Unable to undergo at least one of either a myelogram or spine MRI&#xD;
  &#xD;
            -  Patients for whom external beam treatment plans to deliver the prescription SRS dose&#xD;
               to the lesion of interest cannot be safely designed as specified by the Dose&#xD;
               Constraint Guidelines in Appendix 2&#xD;
  &#xD;
                 -  Evaluation of any radiation doses previously delivered to spinal cord/cauda&#xD;
                    equina and other critical structures (bowel, esophagus, lungs, kidneys, rectum)&#xD;
                    will be taken into consideration&#xD;
  &#xD;
                 -  If radiation dose from SRS would exceed any normal tissue constraint as noted in&#xD;
                    Appendix 2, the patient will be ineligible&#xD;
  &#xD;
            -  Abnormal complete blood count. Any of the following:&#xD;
  &#xD;
                 -  Platelet count &lt; 75 K/µL&#xD;
  &#xD;
                 -  Hgb level &lt; 9 g/dl&#xD;
  &#xD;
                 -  WBC &lt; 3.5 K/µl&#xD;
  &#xD;
            -  Abnormal coagulation profile: INR &gt; 2.5 INR and/or APTT &gt; 80 seconds. Patients who are&#xD;
               on anticoagulation medication that may not be safely held for the myelogram procedure&#xD;
               (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight&#xD;
               heparin formulations) will be excluded.&#xD;
  &#xD;
            -  Allergy to local anesthestics&#xD;
  &#xD;
            -  Local infection at the site of injection of anesthetic&#xD;
  &#xD;
            -  Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)&#xD;
  &#xD;
            -  Severe respiratory disease (i.e. oxygen dependent)&#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>Josh Yamada, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Josh Yamada, MD</last_name>
      <phone>212-639-2950</phone>
      <email>yamadaj@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amitabh Gulati, MD</last_name>
      <phone>212-639-6851</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (Limited Protocol Activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
        <address>
          <city>Uniondale</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Yamada, MD</last_name>
        <phone>212-639-2950</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Stereotactic Radiosurgery (SRS)</keyword>
    <keyword>Ablation of the Dorsal Spinal Nerve</keyword>
    <keyword>22-176</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peritoneal Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985148
  org study id: 22-176
  nct id: NCT05985148
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a
        safe, practical (feasible), and effective treatment for people with chronic TAWP. The
        researchers will test different doses of SRS to find the highest dose that causes few or mild
        side effects.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This is a phase I clinical trial investigating the use of frameless single-fraction stereotactic radiosurgery (SRS) to treat chronic unilateral thoracoabdominal wall pain limited in distribution to three or fewer spinal levels from T3-T11 through ablation of the dorsal spinal nerve root.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: can be escalated from 70 Gy to 90 Gy without excessive DLTs
  time frame: 2 years
  description: DLT's CTCAE grade ≥ 3 toxicity. Acute and late toxicity will be assessed by investigators and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Toxicities that cannot be graded using the Common Toxicity Criteria will be graded as 1 (mildly symptomatic), 2 (moderately symptomatic but not interfering significantly with function), 3 (causing significant interference with function), or 4 (life-threatening).
  arm group label: Single-fraction stereotactic radiosurgery (SRS)
  arm group type: Experimental
  description: Patients will be treated with single-fraction radiation therapy at three dose levels:
  70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.
  intervention type: Radiation
  intervention name: Single-fraction stereotactic radiosurgery (SRS)
  description: Patients will be treated with single-fraction radiation therapy at three dose levels:
  70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.
  arm group label: Single-fraction stereotactic radiosurgery (SRS)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Josh Yamada, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Josh Yamada, MD
  phone: 212-639-2950
  email: yamadaj@mskcc.org
  last name: Amitabh Gulati, MD
  phone: 212-639-6851
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Peritoneal Diseases
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.