<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/NCT04402333</url>
  </required_header>
  <id_info>
    <org_study_id>MIRRORS</org_study_id>
    <nct_id>NCT04402333</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery &amp; Survival</brief_title>
  <acronym>MIRRORS</acronym>
  <official_title>MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery &amp; Survival</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Surrey County Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Surrey County Hospital NHS Foundation Trust</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      MIRRORS &quot;Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer,&#xD;
      Recovery &amp; Survival&quot; is a new United Kingdom based prospective feasibility study the purpose&#xD;
      of which is to establish the feasibility of launching a British multicentre randomised&#xD;
      control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of&#xD;
      the fallopian tube &amp; peritoneum) in the future. This initial feasibility study will focus on&#xD;
      the ability to recruit patients, acceptability, quality of life, the rate at which it is&#xD;
      possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately&#xD;
      the investigators would like to determine whether, in selected patients, robotic surgery&#xD;
      offers improved quality of life and recovery with equivalent overall and progression free&#xD;
      survival.&#xD;
&#xD;
      Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those&#xD;
      with large pelvic masses or extensive disease around the upper part of the abdomen, however,&#xD;
      it has the potential to provide significant recovery and quality of life benefits to a&#xD;
      selected group of patients.&#xD;
&#xD;
      MIRRORS - ICG &quot;Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in&#xD;
      patients with advanced ovarian cancers&quot; is a ancillary study within MIRRORS. Using ICG dye,&#xD;
      the investigators aim to observe whether there are any changes in the blood vessel pattern&#xD;
      associated with the tumour deposits the investigators remove that makes them distinctive. The&#xD;
      ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in&#xD;
      this ancillary research is not required for participation in the trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: in selected cases of ovarian cancer, following neoadjuvant chemotherapy,&#xD;
      minimally invasive robotic surgery provides maximal debulking surgery and improved patient&#xD;
      outcomes.&#xD;
&#xD;
      Null Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer&#xD;
      following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery&#xD;
      and patient outcomes are not improved.&#xD;
&#xD;
      To assess the feasibility of obtaining consent from women and acceptability of Robotic&#xD;
      interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval&#xD;
      debulking surgery will be identified through the Gynaecological Oncology multidisciplinary&#xD;
      team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20&#xD;
      women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian&#xD;
      cancer. The main outcomes are feasibility of the recruitment process and acceptability of the&#xD;
      questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and&#xD;
      patient interviews.&#xD;
&#xD;
      In order to be able to offer MIRRORS to as many patients as possible the investigators have&#xD;
      kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient&#xD;
      comorbidities or Ca125 level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Anticipated">October 3, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 3, 2021</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>Recruitment</measure>
    <time_frame>Assessed at 1 year (recruitment period)</time_frame>
    <description>Number of patients consented compared to the number identified by multidisciplinary team as eligible for inclusion in the study expressed as a percentage.&#xD;
Success criteria: At least 20% of people eligible for the study will accept inclusion in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life following Surgery</measure>
    <time_frame>3 months post surgery</time_frame>
    <description>Assessed using European Organisation for Research and Treatment of Cancer (EORTC) Validated quality of life questionnaire (QLQ) for ovarian cancer (QLQ-C30/QLQ-OV28). This validated questionnaire consists of the core module and its associated ovarian cancer specific module.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental wellbeing</measure>
    <time_frame>3 months post surgery</time_frame>
    <description>Hospital anxiety and depression scale (HADS) A (Anxiety) and D (Depression) scores are calculated separately. 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal (case)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>3 months post surgery</time_frame>
    <description>Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor)</time_frame>
    <description>Intraoperative complications will be recorded. Post operative complications will be recorded and classified by Clavien-Dindo Classification.&#xD;
Success criteria: Complication rate is not higher than for open interval debulking surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Conversion to open surgery</measure>
    <time_frame>Assessed at 1 year 3 months (once last recruited patient has undergone surgery)</time_frame>
    <description>Percentage of patients converted to open surgery after being deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.&#xD;
Success criteria: Conversion to open surgery rate not greater than 50% in patient group deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Robotic interval debulking - Maximal Macroscopic debulking rate (R=0 rate)</measure>
    <time_frame>Assessed at 1 year 3 months (once last recruited patient has undergone surgery)</time_frame>
    <description>Percentage of patients undergoing robotic interval debulking surgery who achieve Maximal macroscopic debulking i.e. no macroscopic residual disease present (R=0 rate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years</time_frame>
    <description>Measured in Months from the date of surgery.&#xD;
In order to follow up long-term survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years</time_frame>
    <description>Measured in Months from the date of surgery until the date of first documented progression.&#xD;
In order to follow up progression free survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period)</time_frame>
    <description>Cost of Robotic minimally invasive interval debulking surgery to the hospital compared to a similar open procedure measured in British Pound (GBP) £</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Ovarian Neoplasm</condition>
  <condition>Ovarian Neoplasm Epithelial</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Peritoneal Cancer</condition>
  <arm_group>
    <arm_group_label>Robotic interval debulking surgery</arm_group_label>
    <description>Surgery will commence with an initial assessment with a camera inserted though the belly button. This visual assessment will be used to determine whether it is feasible to proceed with surgery robotically or whether full debulking surgery to zero macroscopic residual disease would be best carried out through an open surgical approach. If an open surgical approach is considered the optimum treatment for the patient and they have consented for this, then this will be done. If there is disease that cannot be removed Robotically after starting by this route, but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so. If there are any complications, we may also need to convert to open surgery. The aim of the surgery whether by robotic or open is to remove all visible disease safely.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open interval debulking surgery</arm_group_label>
    <description>Standard Care. Following initial laparoscopic assessment patients not deemed suitable for minimally invasive robotic surgery will proceed with standard open interval debulking surgery through an extended midline incision. These patients will also be followed up to assess recovery, complication rate and quality of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic Interval Debulking Surgery</intervention_name>
    <description>Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.</description>
    <arm_group_label>Robotic interval debulking surgery</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumour tissue samples from patients undergoing robotic interval debulking surgery and open&#xD;
      interval debulking surgery. Analysis will involve primarily immunohistochemistry but may&#xD;
      include extracting Ribonucleic acid (RNA).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Suitable participants will be identified during the Royal Surrey NHS Foundation Trust&#xD;
        Gynaecological Oncology multidisciplinary team meeting (MDT).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult women ≥18 years with Stage IIIc -IVb Ovarian cancer (including fallopian tube and&#xD;
        peritoneal cancer) undergoing Neo-adjuvant Chemotherapy.&#xD;
&#xD;
        Considered suitable for Interval debulking surgery&#xD;
&#xD;
        ≤8cm pelvic mass&#xD;
&#xD;
        MIRRORS ICG Inclusion Criteria - Same as above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pelvic mass &gt;8cm, open surgical approach considered necessary following MDT review. Lacking&#xD;
        capacity to the extent they are unable to understand or complete trial documentation /&#xD;
        questionnaires.&#xD;
&#xD;
        MIRRORS ICG Exclusion criteria will be:&#xD;
&#xD;
        Severe renal insufficiency estimated Glomerular filtration rate (GFR)&lt; 55ml/min, known&#xD;
        allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.&#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>Simon Butler-Manuel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Surrey NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christina M Uwins, MRCS MRCOG</last_name>
    <phone>07958143884</phone>
    <email>Christina.Uwins@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kate Penhaligon</last_name>
    <phone>01483 688660</phone>
    <email>k.penhaligon@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Surrey NHS Foundation Trust</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina M Uwins, MRCS, MRCOG</last_name>
      <email>christina.uwins@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</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>Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_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/NCT04402333
org study id: MIRRORS
nct id: NCT04402333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
MIRRORS "Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer,
      Recovery & Survival" is a new United Kingdom based prospective feasibility study the purpose
      of which is to establish the feasibility of launching a British multicentre randomised
      control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of
      the fallopian tube & peritoneum) in the future. This initial feasibility study will focus on
      the ability to recruit patients, acceptability, quality of life, the rate at which it is
      possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately
      the investigators would like to determine whether, in selected patients, robotic surgery
      offers improved quality of life and recovery with equivalent overall and progression free
      survival.

      Robotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those
      with large pelvic masses or extensive disease around the upper part of the abdomen, however,
      it has the potential to provide significant recovery and quality of life benefits to a
      selected group of patients.

      MIRRORS - ICG "Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in
      patients with advanced ovarian cancers" is a ancillary study within MIRRORS. Using ICG dye,
      the investigators aim to observe whether there are any changes in the blood vessel pattern
      associated with the tumour deposits the investigators remove that makes them distinctive. The
      ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in
      this ancillary research is not required for participation in the trial.
Hypothesis: in selected cases of ovarian cancer, following neoadjuvant chemotherapy,
      minimally invasive robotic surgery provides maximal debulking surgery and improved patient
      outcomes.

      Null Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer
      following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery
      and patient outcomes are not improved.

      To assess the feasibility of obtaining consent from women and acceptability of Robotic
      interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval
      debulking surgery will be identified through the Gynaecological Oncology multidisciplinary
      team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20
      women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian
      cancer. The main outcomes are feasibility of the recruitment process and acceptability of the
      questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and
      patient interviews.

      In order to be able to offer MIRRORS to as many patients as possible the investigators have
      kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient
      comorbidities or Ca125 level.
observational model: Cohort
time perspective: Prospective
measure: Recruitment
time frame: Assessed at 1 year (recruitment period)
description: Number of patients consented compared to the number identified by multidisciplinary team as eligible for inclusion in the study expressed as a percentage.
Success criteria: At least 20% of people eligible for the study will accept inclusion in the study.
measure: Quality of Life following Surgery
time frame: 3 months post surgery
description: Assessed using European Organisation for Research and Treatment of Cancer (EORTC) Validated quality of life questionnaire (QLQ) for ovarian cancer (QLQ-C30/QLQ-OV28). This validated questionnaire consists of the core module and its associated ovarian cancer specific module.
measure: Mental wellbeing
time frame: 3 months post surgery
description: Hospital anxiety and depression scale (HADS) A (Anxiety) and D (Depression) scores are calculated separately. 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal (case)
measure: Pain assessment
time frame: 3 months post surgery
description: Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain)
measure: Surgical complications
time frame: Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor)
description: Intraoperative complications will be recorded. Post operative complications will be recorded and classified by Clavien-Dindo Classification.
Success criteria: Complication rate is not higher than for open interval debulking surgery
measure: Rate of Conversion to open surgery
time frame: Assessed at 1 year 3 months (once last recruited patient has undergone surgery)
description: Percentage of patients converted to open surgery after being deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.
Success criteria: Conversion to open surgery rate not greater than 50% in patient group deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.
measure: Robotic interval debulking - Maximal Macroscopic debulking rate (R=0 rate)
time frame: Assessed at 1 year 3 months (once last recruited patient has undergone surgery)
description: Percentage of patients undergoing robotic interval debulking surgery who achieve Maximal macroscopic debulking i.e. no macroscopic residual disease present (R=0 rate)
measure: Overall Survival
time frame: Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years
description: Measured in Months from the date of surgery.
In order to follow up long-term survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee.
measure: Progression free survival
time frame: Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years
description: Measured in Months from the date of surgery until the date of first documented progression.
In order to follow up progression free survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee.
measure: Cost
time frame: Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period)
description: Cost of Robotic minimally invasive interval debulking surgery to the hospital compared to a similar open procedure measured in British Pound (GBP) £
arm group label: Robotic interval debulking surgery
description: Surgery will commence with an initial assessment with a camera inserted though the belly button. This visual assessment will be used to determine whether it is feasible to proceed with surgery robotically or whether full debulking surgery to zero macroscopic residual disease would be best carried out through an open surgical approach. If an open surgical approach is considered the optimum treatment for the patient and they have consented for this, then this will be done. If there is disease that cannot be removed Robotically after starting by this route, but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so. If there are any complications, we may also need to convert to open surgery. The aim of the surgery whether by robotic or open is to remove all visible disease safely.
arm group label: Open interval debulking surgery
description: Standard Care. Following initial laparoscopic assessment patients not deemed suitable for minimally invasive robotic surgery will proceed with standard open interval debulking surgery through an extended midline incision. These patients will also be followed up to assess recovery, complication rate and quality of life.
intervention type: Procedure
intervention name: Robotic Interval Debulking Surgery
description: Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.
arm group label: Robotic interval debulking surgery
Tumour tissue samples from patients undergoing robotic interval debulking surgery and open
      interval debulking surgery. Analysis will involve primarily immunohistochemistry but may
      include extracting Ribonucleic acid (RNA).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Butler-Manuel, MD
role: Principal Investigator
affiliation: Royal Surrey NHS Foundation Trust
last name: Christina M Uwins, MRCS MRCOG
phone: 07958143884
email: Christina.Uwins@nhs.net
last name: Kate Penhaligon
phone: 01483 688660
email: k.penhaligon@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fallopian Tube Neoplasms
sharing ipd: No