xml: <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/NCT05977998</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0331</org_study_id>
      <secondary_id>NCI-2023-05915</secondary_id>
      <nct_id>NCT05977998</nct_id>
    </id_info>
    <brief_title>A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology</brief_title>
    <official_title>A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>M.D. Anderson Cancer Center</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>
        To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of&#xD;
        the stomach) on improving outcomes in patients with gastric cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objectives:&#xD;
  &#xD;
        To assess overall survival from the date of diagnosis in subjects with stage IV gastric or&#xD;
        gastroesophageal cancer and positive cytology or carcinomatosis after perioperative&#xD;
        intraperitoneal paclitaxel and gastrectomy.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
        To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal&#xD;
        cancer and positive cytology or carcinomatosis undergoing treatment with perioperative&#xD;
        intraperitoneal paclitaxel.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2028</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <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 Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0</measure>
      <time_frame>through study completion; an average 1 year.</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Gastric Adenocarcinoma</condition>
    <condition>Carcinomatosis</condition>
    <arm_group>
      <arm_group_label>Paclitaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will receive paclitaxel every 2 weeks for 6 weeks, and then participants may have a gastrectomy based on what the doctor thinks is in your best interest. You may then receive additional paclitaxel every 2 weeks for 6 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paclitaxel</intervention_name>
      <description>Given by IP (Intraperitoneal injection)</description>
      <arm_group_label>Paclitaxel</arm_group_label>
      <other_name>Taxol</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Given by IV (vein)</description>
      <arm_group_label>Paclitaxel</arm_group_label>
      <other_name>Decadron</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Diphenhydramine</intervention_name>
      <description>Given by IV (vein)</description>
      <arm_group_label>Paclitaxel</arm_group_label>
      <other_name>Benadryl®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Famotidine</intervention_name>
      <description>Given by IV (vein)</description>
      <arm_group_label>Paclitaxel</arm_group_label>
      <other_name>Pepcid®</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 years and above. There will be no upper age restriction. Because no dosing or&#xD;
               adverse event data are currently available on the use of intraperitoneal paclitaxel in&#xD;
               patients &lt;18 years of age, children are excluded from this study.&#xD;
  &#xD;
            2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.&#xD;
  &#xD;
            3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal&#xD;
               junction.&#xD;
  &#xD;
            4. Adequate renal, and bone marrow function:&#xD;
  &#xD;
                 1. Leukocytes &gt;= 3,000/uL&#xD;
  &#xD;
                 2. Absolute neutrophil count &gt;= 1,500/uL&#xD;
  &#xD;
                 3. Platelets &gt;= 60,000/Ul&#xD;
  &#xD;
                 4. Serum creatinine &lt;= 1.6 mg/dL&#xD;
  &#xD;
            5. Distant Metastatic Disease of peritoneum:&#xD;
  &#xD;
                 1. Positive peritoneal cytology, or&#xD;
  &#xD;
                 2. Carcinomatosis on diagnostic laparoscopy or laparotomy.&#xD;
  &#xD;
            6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as&#xD;
               HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.&#xD;
  &#xD;
            7. English and non-English speaking patients are eligible.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Distant metastatic disease not limited to the peritoneum such as solid organ&#xD;
               metastases to the liver, central nervous system, or lung.&#xD;
  &#xD;
            2. Infections such as pneumonia or wound infections that would preclude protocol therapy.&#xD;
  &#xD;
            3. Women with a positive urine or serum pregnancy test are excluded from this study;&#xD;
               women of childbearing potential (defined as those who are not postmenopausal defined&#xD;
               as no menses in greater than or equal to 12 months, have not had a hysterectomy or&#xD;
               bilateral salpingo-oophorectomy, do not have ovarian failure, or have not had a&#xD;
               surgical sterilization procedure) must agree to refrain from breast-feeding and&#xD;
               practice adequate contraception as specified in the informed consent. Adequate&#xD;
               contraception consists of oral contraceptive, implantable contraceptives, injectable&#xD;
               contraceptives, a double barrier method, or abstinence. Men with reproductive&#xD;
               potential must agree to an appropriate method of birth control, including abstinence&#xD;
               or double barrier method (diaphragm plus condom).&#xD;
  &#xD;
            4. Subjects with unstable angina or New York Heart Association Grade II or greater&#xD;
               congestive heart failure.&#xD;
  &#xD;
            5. Subjects, such as those with cognitive impairment, deemed unable to comply with study&#xD;
               and/or follow-up procedures.&#xD;
  &#xD;
            6. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was&#xD;
               life-threatening, required hospitalization or prolongation of existing&#xD;
               hospitalization, or resulted in persistent or significant disability or incapacity.&#xD;
  &#xD;
            7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port&#xD;
               placement.&#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>Brian Badgwell, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hsiu-Yin Chang, RN</last_name>
      <phone>713-745-7335</phone>
      <email>hchang@mdanderson.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>M D Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hsiu-Yin Chang, RN</last_name>
        <phone>713-745-7335</phone>
        <email>hchang@mdanderson.org</email>
      </contact>
      <investigator>
        <last_name>Brian Badgwell, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Adenocarcinoma</mesh_term>
      <mesh_term>Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diphenhydramine</mesh_term>
      <mesh_term>Promethazine</mesh_term>
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Famotidine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977998
  org study id: 2023-0331
  secondary id: NCI-2023-05915
  nct id: NCT05977998
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of
        the stomach) on improving outcomes in patients with gastric cancer.
  Primary Objectives:
  
        To assess overall survival from the date of diagnosis in subjects with stage IV gastric or
        gastroesophageal cancer and positive cytology or carcinomatosis after perioperative
        intraperitoneal paclitaxel and gastrectomy.
  
        Secondary Objectives:
  
        To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal
        cancer and positive cytology or carcinomatosis undergoing treatment with perioperative
        intraperitoneal paclitaxel.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
  time frame: through study completion; an average 1 year.
  arm group label: Paclitaxel
  arm group type: Experimental
  description: Participant will receive paclitaxel every 2 weeks for 6 weeks, and then participants may have a gastrectomy based on what the doctor thinks is in your best interest. You may then receive additional paclitaxel every 2 weeks for 6 weeks.
  intervention type: Drug
  intervention name: Paclitaxel
  description: Given by IP (Intraperitoneal injection)
  arm group label: Paclitaxel
  other name: Taxol
  intervention type: Drug
  intervention name: Dexamethasone
  description: Given by IV (vein)
  arm group label: Paclitaxel
  other name: Decadron
  intervention type: Drug
  intervention name: Diphenhydramine
  description: Given by IV (vein)
  arm group label: Paclitaxel
  other name: Benadryl®
  intervention type: Drug
  intervention name: Famotidine
  description: Given by IV (vein)
  arm group label: Paclitaxel
  other name: Pepcid®
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brian Badgwell, MD
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Hsiu-Yin Chang, RN
  phone: 713-745-7335
  email: hchang@mdanderson.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Carcinoma
  mesh term: Diphenhydramine
  mesh term: Promethazine
  mesh term: Dexamethasone
  mesh term: Paclitaxel
  mesh term: Famotidine