<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/NCT03792867</url>
  </required_header>
  <id_info>
    <org_study_id>2017/2012/B</org_study_id>
    <nct_id>NCT03792867</nct_id>
  </id_info>
  <brief_title>Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma</brief_title>
  <official_title>Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Centre, Singapore</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>
      Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and&#xD;
      affects many young people. In approximately 50% of patients, the tumour will reappear in the&#xD;
      same area regardless of therapy. Current treatment involves radical resection; however, it&#xD;
      does not significantly reduce recurrence rates or improve overall survival. Recurrent&#xD;
      retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded.&#xD;
      One of the main challenges in the surgical treatment of this disease is the ability to&#xD;
      accurately identify the local extension of the disease and to prevent local recurrence.&#xD;
&#xD;
      At present, there are no options to prevent recurrence after surgery. In recent years, there&#xD;
      has been increased interest in the use of combined radical surgery with heated&#xD;
      intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of&#xD;
      the tumour including but not limited to surrounding organ resection and normal fat. This is&#xD;
      in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal&#xD;
      cavity that is heated to 40 to 42 degree Celsius.&#xD;
&#xD;
      Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal&#xD;
      cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will&#xD;
      improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn&#xD;
      if this treatment approach will increase locoregional control to reduce recurrence rates and&#xD;
      improve survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 23, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Incidence of treatment-related adverse events</measure>
    <time_frame>From time of resection to one year post-surgery</time_frame>
    <description>To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local recurrence-free survival</measure>
    <time_frame>From time of resection until first occurrence of disease recurrence, up to 3 years</time_frame>
    <description>To determine if the introduction of radical surgery and HIPEC would improve the local recurrence-free survival of patients as compared to current treatment strategies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From time of resection to death from any cause, up to 3 years</time_frame>
    <description>To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Retroperitoneal Sarcoma</condition>
  <arm_group>
    <arm_group_label>Radical Resection and HIPEC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin</intervention_name>
    <description>Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.</description>
    <arm_group_label>Radical Resection and HIPEC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Disease Characteristics&#xD;
&#xD;
               1. Histologically proven soft tissue sarcoma of one of following high-risk groups:&#xD;
&#xD;
                    -  Tumours with grade 2 or 3 histology&#xD;
&#xD;
                    -  Size more than or equal to 5cm&#xD;
&#xD;
                    -  Extracompartmental and deep extension&#xD;
&#xD;
               2. Local recurrence of primary tumour&#xD;
&#xD;
               3. Inadequate surgical excision of previously operated on tumour&#xD;
&#xD;
               4. Proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging&#xD;
                  modality and/ or intraoperative biopsy&#xD;
&#xD;
          2. Patient Characteristics&#xD;
&#xD;
               1. Age: ≥21 years old&#xD;
&#xD;
               2. Performance status: ECOG 0-1&#xD;
&#xD;
               3. Normal haematological, hepatic, coagulation, renal and electrolyte profiles&#xD;
&#xD;
               4. Normal left ventricular ejection fraction&#xD;
&#xD;
               5. Not pregnant or nursing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is medically unfit for surgery due to concurrent medical comorbidities.&#xD;
&#xD;
          2. Any medical or psychiatric condition(s) which would preclude informed consent.&#xD;
&#xD;
          3. Patient is pregnant or nursing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnny Ong, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Centre, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johnny Ong, MD, PhD</last_name>
    <phone>+65 6436 8000</phone>
    <email>johnny.ong.c.a@singhealth.com.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johnny Ong, MD, PhD</last_name>
      <phone>+65 6436 8000</phone>
      <email>johnny.ong.c.a@singhealth.com.sg</email>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</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>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</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/NCT03792867
org study id: 2017/2012/B
nct id: NCT03792867
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and
      affects many young people. In approximately 50% of patients, the tumour will reappear in the
      same area regardless of therapy. Current treatment involves radical resection; however, it
      does not significantly reduce recurrence rates or improve overall survival. Recurrent
      retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded.
      One of the main challenges in the surgical treatment of this disease is the ability to
      accurately identify the local extension of the disease and to prevent local recurrence.

      At present, there are no options to prevent recurrence after surgery. In recent years, there
      has been increased interest in the use of combined radical surgery with heated
      intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of
      the tumour including but not limited to surrounding organ resection and normal fat. This is
      in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal
      cavity that is heated to 40 to 42 degree Celsius.

      Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal
      cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will
      improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn
      if this treatment approach will increase locoregional control to reduce recurrence rates and
      improve survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment-related adverse events
time frame: From time of resection to one year post-surgery
description: To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment
measure: Local recurrence-free survival
time frame: From time of resection until first occurrence of disease recurrence, up to 3 years
description: To determine if the introduction of radical surgery and HIPEC would improve the local recurrence-free survival of patients as compared to current treatment strategies
measure: Overall survival
time frame: From time of resection to death from any cause, up to 3 years
description: To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies
arm group label: Radical Resection and HIPEC
arm group type: Experimental
intervention type: Drug
intervention name: Doxorubicin
description: Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.
arm group label: Radical Resection and HIPEC
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Johnny Ong, MD, PhD
role: Principal Investigator
affiliation: National Cancer Centre, Singapore
last name: Johnny Ong, MD, PhD
phone: +65 6436 8000
email: johnny.ong.c.a@singhealth.com.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Doxorubicin
sharing ipd: No