<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/NCT04415944</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066278</org_study_id>
    <secondary_id>WFBCCC 04619</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <nct_id>NCT04415944</nct_id>
  </id_info>
  <brief_title>Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy</brief_title>
  <acronym>HIPEC</acronym>
  <official_title>A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to see if it is feasible to receive heated chemotherapy&#xD;
      or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time&#xD;
      of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on&#xD;
      participants' health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic&#xD;
      intraperitoneal chemotherapy with carboplatin.&#xD;
&#xD;
      Secondary Objective(s)&#xD;
&#xD;
        -  To compare the quality if life in patients with ovarian cancer after undergoing second&#xD;
           look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy&#xD;
           using carboplatin (CBDCA) versus quality of life in patients treated with cytoreduction&#xD;
           surgery and systemic chemotherapy alone.&#xD;
&#xD;
        -  To describe toxicities in patients with ovarian cancer treated with second look&#xD;
           laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen&#xD;
      also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed for up to 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2021</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>Phase 2</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>Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy</measure>
    <time_frame>Up to 3 months post treatment</time_frame>
    <description>The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire</measure>
    <time_frame>Up to 6 months post-treatment</time_frame>
    <description>The quality of life in patients with advanced ovarian cancer after undergoing second look laparoscopy reassessment surgery with hyperthermic intraperitoneal chemotherapy using Carboplatin (CBDCA) will be determined by the FACT-O questionnaire at pre-study, and months 3, and 6 in follow-up (post-treatment). The distribution of quality of life at each visit and the distribution of change in quality of life at each follow-up visit will be examined and the descriptive statistics will be presented. Scoring scale - (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much) and includes questions relating to Physical Well-Being (7 items), Social Well-being (7 items), Functional Well-Being (7 items), Emotional Well-Being (6 items) and Additional Ovarian Cancer Concerns (12-item). Scores could range from 0-156. Higher scores are associated with better QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Reported Toxicities</measure>
    <time_frame>Up to 3 months post treatment</time_frame>
    <description>Toxicities will be indicated by the number and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. . Counts and percentages will be calculated for each adverse event. Mean, standard deviation, median, and interquartile range will be calculated for number of adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Ovarian Epithelial Cancer Stage I</condition>
  <condition>Ovarian Epithelial Cancer Stage II</condition>
  <condition>Ovarian Epithelial Cancer Stage III</condition>
  <condition>Stage I Fallopian Tube Cancer</condition>
  <condition>Stage II Fallopian Tube Cancer</condition>
  <condition>Stage III Fallopian Tube Cancer</condition>
  <condition>Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Second Look Laparoscopy and HIPEC with Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Second look laparoscopy reassessment surgery (SLLRS)</intervention_name>
    <description>Performed less than 12 weeks after intravenous chemotherapy cycles are completed.</description>
    <arm_group_label>Second Look Laparoscopy and HIPEC with Carboplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HIPEC with Carboplatin</intervention_name>
    <description>Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.&#xD;
Patients who exhibit the following will not receive the HIPEC procedure:&#xD;
Extraperitoneal disease noted at the time of the second look procedure&#xD;
Macroscopic intraperitoneal disease which is not resectable to R1&#xD;
Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion&#xD;
Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC&#xD;
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.</description>
    <arm_group_label>Second Look Laparoscopy and HIPEC with Carboplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FACT-O Quality of Life Questionnaire</intervention_name>
    <description>Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.</description>
    <arm_group_label>Second Look Laparoscopy and HIPEC with Carboplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian&#xD;
             tube or peritoneum or Stage IVA disease in which is there complete resolution of&#xD;
             disease (pleural effusion) with chemotherapy&#xD;
&#xD;
          -  Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based&#xD;
             systemic chemotherapy prior to the second look surgery. Systemic platinum based&#xD;
             chemotherapy must be completed less than 18 weeks prior to second look surgery.&#xD;
&#xD;
          -  Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic&#xD;
             chemotherapy&#xD;
&#xD;
          -  The intraoperative peritoneal adhesion index should be &lt; 10.&#xD;
&#xD;
          -  Patients must be without clinical evidence of disease including a negative exam,&#xD;
             imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  ECOG performance status ≤ 2.&#xD;
&#xD;
          -  Patients must have adequate organ and marrow function as defined below (within 30 days&#xD;
             of registration): absolute neutrophil count &gt;1,500/mcL; platelets &gt;100,000/mcL; total&#xD;
             bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X;&#xD;
             institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit&#xD;
             of normal&#xD;
&#xD;
          -  Adequate contraception and negative pregnancy test if pregnancy possible.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an IRB-approved informed consent&#xD;
             document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients greater than 18 weeks from their last course of systemic platinum based&#xD;
             chemotherapy&#xD;
&#xD;
          -  Patients who have received additional chemotherapy for the ovarian cancer after&#xD;
             primary therapy as outlined above.&#xD;
&#xD;
          -  Patients may not have received prior abdominal or pelvic radiation.&#xD;
&#xD;
          -  Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive&#xD;
             surgery with PAI of &gt;10 as defined above&#xD;
&#xD;
          -  Intra-abdominal infection associated with initial cytoreductive surgery requiring&#xD;
             extended hospitalization or related to systemic chemotherapy requiring hospitalization&#xD;
             for therapy&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to carboplatin.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
        Men are excluded from participation due to the site-specific nature of the disease being&#xD;
        studied.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel S. Lentz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Nurse</last_name>
    <phone>336-713-3539</phone>
    <email>arcarrol@wakehealth.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wake Forest Baptist Comprehensive Cancer Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Nurse</last_name>
      <phone>335-713-3539</phone>
      <email>arcarrol@wakehealth.edu</email>
    </contact>
    <investigator>
      <last_name>Samuel S Lentz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 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>Fallopian Tube Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04415944
org study id: IRB00066278
secondary id: WFBCCC 04619
secondary id: P30CA012197
nct id: NCT04415944
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this research study is to see if it is feasible to receive heated chemotherapy
      or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time
      of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on
      participants' health.
Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic
      intraperitoneal chemotherapy with carboplatin.

      Secondary Objective(s)

        -  To compare the quality if life in patients with ovarian cancer after undergoing second
           look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy
           using carboplatin (CBDCA) versus quality of life in patients treated with cytoreduction
           surgery and systemic chemotherapy alone.

        -  To describe toxicities in patients with ovarian cancer treated with second look
           laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.

      OUTLINE:

      Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen
      also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for up to 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
time frame: Up to 3 months post treatment
description: The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.
measure: Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
time frame: Up to 6 months post-treatment
description: The quality of life in patients with advanced ovarian cancer after undergoing second look laparoscopy reassessment surgery with hyperthermic intraperitoneal chemotherapy using Carboplatin (CBDCA) will be determined by the FACT-O questionnaire at pre-study, and months 3, and 6 in follow-up (post-treatment). The distribution of quality of life at each visit and the distribution of change in quality of life at each follow-up visit will be examined and the descriptive statistics will be presented. Scoring scale - (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much) and includes questions relating to Physical Well-Being (7 items), Social Well-being (7 items), Functional Well-Being (7 items), Emotional Well-Being (6 items) and Additional Ovarian Cancer Concerns (12-item). Scores could range from 0-156. Higher scores are associated with better QOL.
measure: Number of Reported Toxicities
time frame: Up to 3 months post treatment
description: Toxicities will be indicated by the number and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. . Counts and percentages will be calculated for each adverse event. Mean, standard deviation, median, and interquartile range will be calculated for number of adverse events.
arm group label: Second Look Laparoscopy and HIPEC with Carboplatin
arm group type: Experimental
description: Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
intervention type: Procedure
intervention name: Second look laparoscopy reassessment surgery (SLLRS)
description: Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
arm group label: Second Look Laparoscopy and HIPEC with Carboplatin
intervention type: Drug
intervention name: HIPEC with Carboplatin
description: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
Extraperitoneal disease noted at the time of the second look procedure
Macroscopic intraperitoneal disease which is not resectable to R1
Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
arm group label: Second Look Laparoscopy and HIPEC with Carboplatin
intervention type: Other
intervention name: FACT-O Quality of Life Questionnaire
description: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
arm group label: Second Look Laparoscopy and HIPEC with Carboplatin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel S. Lentz, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Study Nurse
phone: 336-713-3539
email: arcarrol@wakehealth.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Fallopian Tube Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Carboplatin
sharing ipd: No