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/NCT06017284</url>
    </required_header>
    <id_info>
      <org_study_id>PTCA199-5</org_study_id>
      <nct_id>NCT06017284</nct_id>
    </id_info>
    <brief_title>Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer</brief_title>
    <acronym>PTCA199-5</acronym>
    <official_title>Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality&#xD;
        of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel&#xD;
        chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%.&#xD;
        Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage.&#xD;
        Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic&#xD;
        Pancreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with&#xD;
        nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the&#xD;
        side-effects related to gemcitabine combined with nab-paclitaxel including nausea/vomiting,&#xD;
        insomnia, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.&#xD;
  &#xD;
        Thalidomide is an oral medication used to treat a number of cancers (e.g. multiple myeloma),&#xD;
        graft-versus-host disease, and many skin disorders (e.g. complications of leprosy such as&#xD;
        skin lesions). It caused severe malformations in babies born to mothers taking the drug for&#xD;
        morning sickness in the late 1950s and early 1960s. Thalidomide works on the immune system to&#xD;
        reduce inflammation. Thalidomide may enhance the tolerability of chemotherapy by reducing&#xD;
        nausea/vomiting, improving sleeping quality, alleviating pain, and thus improving quality of&#xD;
        life for patients with pancreatic cancer.&#xD;
  &#xD;
        The purpose of this study is to evaluate the efficacy of Thalidomide on improving the quality&#xD;
        of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel&#xD;
        chemotherapy. One hundred patients will be randomly assigned to the experimental group&#xD;
        (gemcitabine combined with nab-paclitaxel, Thalidomide) or the control group (gemcitabine&#xD;
        combined with nab-paclitaxel). Rate of nausea/vomiting, index of sleep quality, severity of&#xD;
        pain, quality of life, and overall survival are measured every four weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</primary_completion_date>
    <phase>Phase 3</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of nausea/vomiting</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain numeric rating scale (NRS)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Change of pain numeric rating scale after every cycle of chemotherapy. The administration of analgesic drugs after every cycle of chemotherapy is recorded. The range of NRS scale is 0-10 and higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QOL)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality index</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
      <description>OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Pancreatic Cancer Stage IV</condition>
    <condition>Chemotherapy-induced Nausea and Vomiting</condition>
    <arm_group>
      <arm_group_label>Chemotherapy + Thalidomide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chemotherapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. .</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Thalidomide</intervention_name>
      <description>Thalidomide 100 mg/day, once a day, orally intake at night.</description>
      <arm_group_label>Chemotherapy + Thalidomide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nab paclitaxel</intervention_name>
      <description>nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.</description>
      <arm_group_label>Chemotherapy</arm_group_label>
      <arm_group_label>Chemotherapy + Thalidomide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.</description>
      <arm_group_label>Chemotherapy</arm_group_label>
      <arm_group_label>Chemotherapy + Thalidomide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
  &#xD;
            -  Age ≥ 18 years and ≤ 80 years.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.&#xD;
  &#xD;
            -  Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.&#xD;
  &#xD;
            -  Adequate organ performance based on laboratory blood tests.&#xD;
  &#xD;
            -  Presence of at least of one measurable lesion in agreement to Response Evaluation&#xD;
               Criteria in Solid Tumors (RECIST) criteria.&#xD;
  &#xD;
            -  The expected survival ≥ 3 months.&#xD;
  &#xD;
            -  Women of childbearing potential and men must agree to use adequate contraception prior&#xD;
               to study entry and for the duration of study participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have received any form of anti-tumor therapy.&#xD;
  &#xD;
            -  The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.&#xD;
  &#xD;
            -  Inflammation of the digestive tract, including pancreatitis, cholecystitis,&#xD;
               cholangitis, etc.&#xD;
  &#xD;
            -  Pregnant or nursing women.&#xD;
  &#xD;
            -  Severe and uncontrollable accompanying diseases that may affect protocol compliance or&#xD;
               interfere with the interpretation of results, including active opportunistic&#xD;
               infections or advanced (severe) infections, and diabetes that cannot be controlled&#xD;
               after adequate clinical anti-hyperglycemia treatment according to guidelines,&#xD;
               uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as&#xD;
               defined by the New York Heart Association classification, congestive heart failure&#xD;
               (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable&#xD;
               angina, cerebral infarction within 3 months, etc).&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to gemcitabine, nab-paclitaxel, or other agents used in the study.&#xD;
  &#xD;
            -  Other serious accompanying illnesses, which, in the researcher's opinion, could&#xD;
               seriously adversely affect the safety of the treatment.&#xD;
  &#xD;
            -  Patients who are unwilling or unable to comply with study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guopei Luo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ying Yang, MD</last_name>
      <phone>86 64175590</phone>
      <phone_ext>1307</phone_ext>
      <email>yangying@fudanpci.org</email>
    </overall_contact>
    <reference>
      <citation>Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.</citation>
      <PMID>28854065</PMID>
    </reference>
    <reference>
      <citation>Hwu WJ, Krown SE, Menell JH, Panageas KS, Merrell J, Lamb LA, Williams LJ, Quinn CJ, Foster T, Chapman PB, Livingston PO, Wolchok JD, Houghton AN. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3351-6. doi: 10.1200/JCO.2003.02.061.</citation>
      <PMID>12947072</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Guopei Luo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>chemotherapy</keyword>
    <keyword>pancreatic cancer</keyword>
    <keyword>Thalidomide</keyword>
    <keyword>nausea</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thalidomide</mesh_term>
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06017284
  org study id: PTCA199-5
  nct id: NCT06017284
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality
        of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel
        chemotherapy.
  Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%.
        Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage.
        Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic
        Pancreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with
        nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the
        side-effects related to gemcitabine combined with nab-paclitaxel including nausea/vomiting,
        insomnia, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
  
        Thalidomide is an oral medication used to treat a number of cancers (e.g. multiple myeloma),
        graft-versus-host disease, and many skin disorders (e.g. complications of leprosy such as
        skin lesions). It caused severe malformations in babies born to mothers taking the drug for
        morning sickness in the late 1950s and early 1960s. Thalidomide works on the immune system to
        reduce inflammation. Thalidomide may enhance the tolerability of chemotherapy by reducing
        nausea/vomiting, improving sleeping quality, alleviating pain, and thus improving quality of
        life for patients with pancreatic cancer.
  
        The purpose of this study is to evaluate the efficacy of Thalidomide on improving the quality
        of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel
        chemotherapy. One hundred patients will be randomly assigned to the experimental group
        (gemcitabine combined with nab-paclitaxel, Thalidomide) or the control group (gemcitabine
        combined with nab-paclitaxel). Rate of nausea/vomiting, index of sleep quality, severity of
        pain, quality of life, and overall survival are measured every four weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of nausea/vomiting
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.
  measure: Pain numeric rating scale (NRS)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Change of pain numeric rating scale after every cycle of chemotherapy. The administration of analgesic drugs after every cycle of chemotherapy is recorded. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
  measure: Quality of life (QOL)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  measure: Sleep quality index
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)
  measure: Overall survival (OS)
  time frame: At the end of Cycle 1 (each cycle is 28 days)
  description: OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
  arm group label: Chemotherapy + Thalidomide
  arm group type: Experimental
  description: nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
  arm group label: Chemotherapy
  arm group type: Active Comparator
  description: nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. .
  intervention type: Drug
  intervention name: Thalidomide
  description: Thalidomide 100 mg/day, once a day, orally intake at night.
  arm group label: Chemotherapy + Thalidomide
  intervention type: Drug
  intervention name: Nab paclitaxel
  description: nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.
  arm group label: Chemotherapy
  arm group label: Chemotherapy + Thalidomide
  intervention type: Drug
  intervention name: Gemcitabine
  description: gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
  arm group label: Chemotherapy
  arm group label: Chemotherapy + Thalidomide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Guopei Luo, MD
  role: Principal Investigator
  affiliation: Fudan University
  last name: Ying Yang, MD
  phone: 86 64175590
  phone ext: 1307
  email: yangying@fudanpci.org
  citation: Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.
  PMID: 28854065
  citation: Hwu WJ, Krown SE, Menell JH, Panageas KS, Merrell J, Lamb LA, Williams LJ, Quinn CJ, Foster T, Chapman PB, Livingston PO, Wolchok JD, Houghton AN. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3351-6. doi: 10.1200/JCO.2003.02.061.
  PMID: 12947072
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Guopei Luo
  investigator title: Professor
  mesh term: Pancreatic Neoplasms
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Thalidomide
  mesh term: Paclitaxel
  mesh term: Gemcitabine
  sharing ipd: No