<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/NCT03258541</url>
  </required_header>
  <id_info>
    <org_study_id>TraceIT_01268</org_study_id>
    <nct_id>NCT03258541</nct_id>
  </id_info>
  <brief_title>Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy</brief_title>
  <official_title>TraceIT® Hydrogel Spacer Injections for Vagina and Erectile Bundles Sparing in Rectal Cancer Patients Treated With Neoadjuvant Radiotherapy: a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Zilli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/-&#xD;
      chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing&#xD;
      local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects,&#xD;
      especially in terms of impaired sexual function. For females, pelvic RT is frequently&#xD;
      associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and&#xD;
      dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and&#xD;
      penile bulb have been associated to the risk to develop erectile dysfunction.&#xD;
&#xD;
      In prostate cancer, hydrogel spacers have been evaluated to create space between the target&#xD;
      (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical&#xD;
      studies have shown the ease of spacer application; patient tolerance and, good clinical&#xD;
      outcomes (decrease in rectal toxicities).&#xD;
&#xD;
      This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel&#xD;
      spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a feasibility prospective pilot study. Ten patients (5 males and 5 females) with a&#xD;
      histologically proven locally advanced rectal cancer with the indication of neoadjuvant&#xD;
      radiotherapy or radio-chemotherapy will be recruited for this study. Prior to enrollment,&#xD;
      potential candidates will undergo a thorough physical and clinical examination and&#xD;
      documentation on medical and surgical history. If eligible, a baseline planning computed&#xD;
      tomography (CT) simulation will be performed at the Radiation Oncology Department before the&#xD;
      TraceIT® implant. Participants will undergo a transperineal injection of TraceIT® spacer gel&#xD;
      between rectum and vagina or prostate performed by a trained radiologist under transrectal&#xD;
      ultrasound guidance. A CT simulation will be repeated within 3 to 5 days post injection using&#xD;
      the same imaging modality and treatment position used the pre- TraceIT® injection. Radiation&#xD;
      treatment plans will be generated using scans realized pre- and post- TraceIT® injection and&#xD;
      compared using dose volume histograms (DVH) analyses. Tolerance, side effects, and adverse&#xD;
      events related to the procedure will be recorded prospectively from the injection until&#xD;
      week-4 after EBRT (External Beam Radiation Therapy) completion. Radiological status of the&#xD;
      spacer will be evaluated on the preoperative magnetic resonance Imaging (MRI).&#xD;
      Histopathological results and any serious and/or unanticipated adverse events following&#xD;
      surgery procedure will be recorded retrospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Surgical access not facilitated- residues of hydrogel.&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</primary_completion_date>
  <phase>N/A</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>Clinical performance</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of serious adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparative dosimetric studies</measure>
    <time_frame>2 years</time_frame>
    <description>Dosimetric parameters to determine effectiveness of this technique to reduce RT (radiotherapy) doses to the vagina/erectile bundles as assessed by comparative dosimetric studies.</description>
  </secondary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>Rectal Tumors</condition>
  <condition>Rectal Cancer</condition>
  <condition>Advanced Cancer</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TraceIT®</intervention_name>
    <description>This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.</description>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Volumetric Arc Therapy (VMAT)</intervention_name>
    <description>VMAT - fractionation Schedule : 1.8 Gy per fraction, one fraction per day, 5 fractions per week for the elective PTV and 2 Gy per fraction, one fraction per day, 5 fractions per week for the PTV-boost using a simultaneous integrated boost technique.</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Low anterior resection of the rectum: 8-10 weeks post-radiotherapy</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  WHO (World Health Organization) performance status 0-1 at registration&#xD;
&#xD;
          -  Locally advanced (T1-2 node positive or T3 N0/N+) histologically proven rectal&#xD;
             adenocarcinoma located in the middle or in the high rectum. Patients with tumors&#xD;
             located in the lower rectum may be eligible if the location of the tumor do not&#xD;
             preclude the implant of the spacer (i.e. tumors located anteriorly in the proximity of&#xD;
             the anal sphincter)&#xD;
&#xD;
          -  Indication for preoperative radiotherapy or radio-chemotherapy&#xD;
&#xD;
          -  Absence of any psychological, familial, sociological, or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule; those&#xD;
             conditions should be discussed with the patient before registration in the trial&#xD;
&#xD;
          -  Before patient registration/randomization, written informed consent must be given&#xD;
             according to GCP/ICH (Guideline for Good Clinical Practice/Harmonised Tripartite&#xD;
             Guideline), and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient &lt;18 years old&#xD;
&#xD;
          -  WHO performance status ≥ 2 at registration&#xD;
&#xD;
          -  Patient with a local extension, clinical stage T4 and/or presenting a&#xD;
             vagina/prostate/bladder invasion&#xD;
&#xD;
          -  Active bleeding disorder or clinically significant coagulopathy (PTT &gt;35sec/ or INR&#xD;
             &gt;1.4 (INR, international normalized ratio). Or platelet count &lt; 100'000/mm3)&#xD;
&#xD;
          -  Active inflammatory or infectious process involving the perineum, gastrointestinal or&#xD;
             urinary tract&#xD;
&#xD;
          -  Compromised immune system (e.g. HIV/acquired immunodeficiency syndrome, autoimmune&#xD;
             disease or immunosuppressive therapy)&#xD;
&#xD;
          -  History of previous pelvic surgery&#xD;
&#xD;
          -  History of active inflammatory bowel disease (Crohn's disease, ulcerative colitis,&#xD;
             irritable bowel disease)&#xD;
&#xD;
          -  Contraindication for MRI&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Inability to provide a written informed consent&#xD;
&#xD;
          -  Inability to comply with study and follow up procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Geneva</name>
      <address>
        <city>Genève</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>May 13, 2020</last_update_submitted>
  <last_update_submitted_qc>May 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Thomas Zilli</investigator_full_name>
    <investigator_title>MD, PD, Médecin adjoint agrégé</investigator_title>
  </responsible_party>
  <keyword>TraceIT®</keyword>
  <keyword>Hydrogel spacer</keyword>
  <keyword>Rectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT03258541
org study id: TraceIT_01268
nct id: NCT03258541
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/-
      chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing
      local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects,
      especially in terms of impaired sexual function. For females, pelvic RT is frequently
      associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and
      dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and
      penile bulb have been associated to the risk to develop erectile dysfunction.

      In prostate cancer, hydrogel spacers have been evaluated to create space between the target
      (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical
      studies have shown the ease of spacer application; patient tolerance and, good clinical
      outcomes (decrease in rectal toxicities).

      This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel
      spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.
This is a feasibility prospective pilot study. Ten patients (5 males and 5 females) with a
      histologically proven locally advanced rectal cancer with the indication of neoadjuvant
      radiotherapy or radio-chemotherapy will be recruited for this study. Prior to enrollment,
      potential candidates will undergo a thorough physical and clinical examination and
      documentation on medical and surgical history. If eligible, a baseline planning computed
      tomography (CT) simulation will be performed at the Radiation Oncology Department before the
      TraceIT® implant. Participants will undergo a transperineal injection of TraceIT® spacer gel
      between rectum and vagina or prostate performed by a trained radiologist under transrectal
      ultrasound guidance. A CT simulation will be repeated within 3 to 5 days post injection using
      the same imaging modality and treatment position used the pre- TraceIT® injection. Radiation
      treatment plans will be generated using scans realized pre- and post- TraceIT® injection and
      compared using dose volume histograms (DVH) analyses. Tolerance, side effects, and adverse
      events related to the procedure will be recorded prospectively from the injection until
      week-4 after EBRT (External Beam Radiation Therapy) completion. Radiological status of the
      spacer will be evaluated on the preoperative magnetic resonance Imaging (MRI).
      Histopathological results and any serious and/or unanticipated adverse events following
      surgery procedure will be recorded retrospectively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical performance
time frame: 2 years
description: Incidence of serious adverse events.
measure: Comparative dosimetric studies
time frame: 2 years
description: Dosimetric parameters to determine effectiveness of this technique to reduce RT (radiotherapy) doses to the vagina/erectile bundles as assessed by comparative dosimetric studies.
intervention type: Device
intervention name: TraceIT®
description: This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.
intervention type: Radiation
intervention name: Volumetric Arc Therapy (VMAT)
description: VMAT - fractionation Schedule : 1.8 Gy per fraction, one fraction per day, 5 fractions per week for the elective PTV and 2 Gy per fraction, one fraction per day, 5 fractions per week for the PTV-boost using a simultaneous integrated boost technique.
intervention type: Procedure
intervention name: Surgery
description: Low anterior resection of the rectum: 8-10 weeks post-radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Thomas Zilli
investigator title: MD, PD, Médecin adjoint agrégé
mesh term: Rectal Neoplasms
sharing ipd: No