<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/NCT03792269</url>
  </required_header>
  <id_info>
    <org_study_id>mCRC-PC</org_study_id>
    <nct_id>NCT03792269</nct_id>
  </id_info>
  <brief_title>Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC</brief_title>
  <official_title>An Open-label, Randomized, Phase II Clinical Trial Comparing the Efficacy and Safety of Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
      XELOX as first-line treatment regimen has limited efficacy against patients with metastatic&#xD;
      colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC.&#xD;
      Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of&#xD;
      peritoneal dissemination. We hypothesized that combined multi-channel administration, such as&#xD;
      intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce&#xD;
      better results than XELOX for first-line treatment for mCRC patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>up to 1 year</time_frame>
    <description>PFS is the period between the first course of treatment to disease recurrence. The follow-up work will be performed every 6 weeks until disease recurrence or loss to follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>OS is the period between the first course of treatment to death. The follow-up work will be performed every 3 months until death or loss to follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>CT/MRI will be performed every 2 cycles of treatment for short-term efficacy. evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AE)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Adverse effects will be recorded during the whole treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colorectal Cancer Metastatic</condition>
  <condition>Chemotherapy Effect</condition>
  <condition>Chemotherapeutic Toxicity</condition>
  <arm_group>
    <arm_group_label>Multi-channel chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive intravenous oxaliplatin (130mg/m^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>intraperitoneal</description>
    <arm_group_label>Multi-channel chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>intravenous</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Oral</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must have histologically confirmed adenocarcinoma of clorectal with inoperable&#xD;
        locally advanced or metastatic disease, not amenable to curative therapy.&#xD;
&#xD;
        Patients must have measurable disease, according to the Response Evaluation Criteria in&#xD;
        Solid Tumors (RECIST, v1.1), assessed using imaging techniques (CT or MRI).&#xD;
&#xD;
        Women of childbearing potential must be non-pregnant (negative pregnancy test within 72&#xD;
        hours prior to chemotherapy, postmenopausal woman must have been amenorrheic for at least&#xD;
        12 months to be considered of non-childbearing potential) and nonlactating, and men and&#xD;
        women must be willing to exercise an effective form of birth control&#xD;
        (abstinence/contraception) while on study and for 6 months after therapy completed Eastern&#xD;
        Cooperative Oncology Group (ECOG) Performance status 0, 1 or 2. Absolute neutrophil count&#xD;
        (ANC) &gt;=1,500/ul Platelets (PLT) &gt;=75,000/ul Serum bilirubin &lt;= 1.5 × upper limit of normal&#xD;
        (ULN) Aspartate transaminase (AST) or alanine aminotransferase (ALT) &lt;= 2.5 × ULN (or &lt;= 5&#xD;
        × ULN in patients with liver metastases) Alkaline phosphatase &lt;= 2.5 × ULN (or &lt;= 5 × ULN&#xD;
        in patients with liver metastases, or &lt;= 10 × ULN in patients with bone but no liver&#xD;
        metastases) Albumin &gt;= 25 g/L. Creatinine clearance &gt;= 60 mL/min. Life expectancy of at&#xD;
        least 3 months. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy&#xD;
        is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant&#xD;
        therapy and enrolment into the study).&#xD;
&#xD;
        Patients with active (significant or uncontrolled) gastrointestinal bleeding. Residual&#xD;
        relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g.&#xD;
        neurological toxicity ≥ grade 2 NCI-CTCAE 4.0.&#xD;
&#xD;
        Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or&#xD;
        basal cell carcinoma.&#xD;
&#xD;
        History of documented congestive heart failure; angina pectoris requiring&#xD;
        medication;evidence of transmural myocardial infarction on ECG; poorly controlled&#xD;
        hypertension (systolic BP &gt; 180 mmHg or diastolic BP &gt; 100 mmHg); clinically significant&#xD;
        valvular heart disease; or high risk uncontrollable arrhythmias.&#xD;
&#xD;
        Baseline left ventricular ejection fraction (LVEF) &lt; 50% (measured by echocardiography or&#xD;
        MUGA).&#xD;
&#xD;
        Patients with dyspnoea at rest due to complications of advanced malignancy or other&#xD;
        disease, or who require supportive oxygen therapy.&#xD;
&#xD;
        Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short&#xD;
        courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).&#xD;
&#xD;
        Clinically significant hearing abnormality. Known dihydropyrimidine dehydrogenase (DPD)&#xD;
        deficiency. History or clinical evidence of brain metastases. Serious uncontrolled systemic&#xD;
        intercurrent illness, e.g. infections or poorly controlled diabetes.&#xD;
&#xD;
        Positive serum pregnancy test in women of childbearing potential. Received any&#xD;
        investigational drug treatment within 4 weeks of start of study treatment.&#xD;
&#xD;
        Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if&#xD;
        palliative radiotherapy given to bone metastatic site peripherally and patient recovered&#xD;
        from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6&#xD;
        months ).&#xD;
&#xD;
        Major surgery within 4 weeks of start of study treatment, without complete recovery.&#xD;
&#xD;
        Patients with known active infection with HIV, hepatitis B virus (HBV), or hepatitis C&#xD;
        virus (HCV).&#xD;
&#xD;
        Known hypersensitivity to any of the study drugs.&#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>Jing Jing</last_name>
    <role>Study Chair</role>
    <affiliation>The Comprehensive Cancer Center of Nanjing Drum Tower Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Hu, M.D., P.hD</last_name>
    <phone>0086-13057668736</phone>
    <email>doctorhujing@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoping Qian, M.D., P.hD</last_name>
    <phone>0086-13851763162</phone>
    <email>qianxiaoping211@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Comprehensive Cancer Center of Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Hu, M.D., P.hD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Jing Hu</investigator_full_name>
    <investigator_title>investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</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/NCT03792269
org study id: mCRC-PC
nct id: NCT03792269
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
XELOX as first-line treatment regimen has limited efficacy against patients with metastatic
      colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC.
      Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of
      peritoneal dissemination. We hypothesized that combined multi-channel administration, such as
      intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce
      better results than XELOX for first-line treatment for mCRC patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Progression-free Survival (PFS)
time frame: up to 1 year
description: PFS is the period between the first course of treatment to disease recurrence. The follow-up work will be performed every 6 weeks until disease recurrence or loss to follow-up.
measure: Overall Survival (OS)
time frame: up to 2 years
description: OS is the period between the first course of treatment to death. The follow-up work will be performed every 3 months until death or loss to follow-up.
measure: Objective Response Rate (ORR)
time frame: up to 24 weeks
description: CT/MRI will be performed every 2 cycles of treatment for short-term efficacy. evaluation
measure: Adverse Events (AE)
time frame: up to 2 years
description: Adverse effects will be recorded during the whole treatment.
arm group label: Multi-channel chemotherapy
arm group type: Experimental
description: Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).
arm group label: Control Group
arm group type: Active Comparator
description: Patients will receive intravenous oxaliplatin (130mg/m^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).
intervention type: Drug
intervention name: Irinotecan
description: intraperitoneal
arm group label: Multi-channel chemotherapy
intervention type: Drug
intervention name: Oxaliplatin
description: intravenous
arm group label: Control Group
intervention type: Drug
intervention name: Capecitabine
arm group label: Control Group
other name: Oral
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jing Jing
role: Study Chair
affiliation: The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
last name: Jing Hu, M.D., P.hD
phone: 0086-13057668736
email: doctorhujing@hotmail.com
last name: Xiaoping Qian, M.D., P.hD
phone: 0086-13851763162
email: qianxiaoping211@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Jing Hu
investigator title: investigator
mesh term: Colorectal Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Irinotecan
sharing ipd: No