<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/NCT03034395</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2016-JM-MEL-T2Margins</org_study_id>
    <nct_id>NCT03034395</nct_id>
  </id_info>
  <brief_title>Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma</brief_title>
  <official_title>Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical 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>
      This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who&#xD;
      are candidates for surgical resection. The primary objective is to determine the feasibility&#xD;
      of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm&#xD;
      versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant&#xD;
      melanoma after surgical treatment with 1cm versus 2cm margins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After randomization, participants will undergo surgery with wide local excision with either&#xD;
      1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of&#xD;
      pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure&#xD;
      considerations may require removal of additional tissue for non-oncologic purposes. As per&#xD;
      standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique&#xD;
      (technetium radiolabeled sulfur colloid and isosulfan blue) with or without&#xD;
      lymphoscintigraphy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">November 4, 2020</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.</measure>
    <time_frame>2 years</time_frame>
    <description>Number of patients who agree to participate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence (disease free survival)</measure>
    <time_frame>Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years</time_frame>
    <description>Subjects will be evaluated at 4 month intervals for 2 years and then at 4-6 month intervals for an additional 3 years to evaluate for evidence of disease recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life following surgery</measure>
    <time_frame>One month post-surgery</time_frame>
    <description>Measured by FACT-Melanoma Surgery Subscale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Malignant Melanoma</condition>
  <arm_group>
    <arm_group_label>Wide Local Excision 1cm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Wide Local Excision 2cm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Wide Local Excision</intervention_name>
    <description>Surgery</description>
    <arm_group_label>Wide Local Excision 1cm</arm_group_label>
    <arm_group_label>Wide Local Excision 2cm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy proven T2 malignant melanoma.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) score of 0-2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visible additional disease that suggests a greater than T2 malignant melanoma&#xD;
&#xD;
          -  Unable to tolerate general anesthesia&#xD;
&#xD;
          -  Evidence of distant metastatic disease&#xD;
&#xD;
          -  Melanoma located on face or digits&#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>Joshua Mammen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Melanoma</keyword>
  <keyword>cT2N0M0</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</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/NCT03034395
org study id: IIT-2016-JM-MEL-T2Margins
nct id: NCT03034395
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who
      are candidates for surgical resection. The primary objective is to determine the feasibility
      of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm
      versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant
      melanoma after surgical treatment with 1cm versus 2cm margins.
After randomization, participants will undergo surgery with wide local excision with either
      1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of
      pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure
      considerations may require removal of additional tissue for non-oncologic purposes. As per
      standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique
      (technetium radiolabeled sulfur colloid and isosulfan blue) with or without
      lymphoscintigraphy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.
time frame: 2 years
description: Number of patients who agree to participate
measure: Recurrence (disease free survival)
time frame: Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years
description: Subjects will be evaluated at 4 month intervals for 2 years and then at 4-6 month intervals for an additional 3 years to evaluate for evidence of disease recurrence.
measure: Quality of life following surgery
time frame: One month post-surgery
description: Measured by FACT-Melanoma Surgery Subscale
arm group label: Wide Local Excision 1cm
arm group type: Other
arm group label: Wide Local Excision 2cm
arm group type: Other
intervention type: Procedure
intervention name: Wide Local Excision
description: Surgery
arm group label: Wide Local Excision 1cm
arm group label: Wide Local Excision 2cm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua Mammen, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Melanoma