<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/NCT03279614</url>
  </required_header>
  <id_info>
    <org_study_id>SOX-2</org_study_id>
    <nct_id>NCT03279614</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficiency of SOX as Seconde-line Chemotherapy in Neuroendocrine Carcinoma</brief_title>
  <official_title>Phase II Study of SOX as the Seconde Line Chemotherapy in Advanced or Metastatic Neuroendocrine Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Currently, there is no standard second line treatment for patients with neuroendocrine&#xD;
      carcinoma. SOX regimen has shown promising in previous study. The study was designed to&#xD;
      confirm thet SOX regimen can be used as a second-line regimen for patients with advanced or&#xD;
      metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with&#xD;
      platinum based regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>Phase 2</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>Overall response rate (ORR)</measure>
    <time_frame>From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation by RECIST 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>baseline, every 8 weeks up to 1 year after last patient first treatment</time_frame>
    <description>Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>baseline, every 8 weeks up to 1 year after last patient first treatment</time_frame>
    <description>Overall survival is defined as the time from date of start of treatment to date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-related Adverse Events （Safety and Tolerability）</measure>
    <time_frame>From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Neuroendocrine Carcinoma</condition>
  <arm_group>
    <arm_group_label>SOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOX</intervention_name>
    <description>OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W</description>
    <arm_group_label>SOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. sign written informed consent form&#xD;
&#xD;
          2. age ≥ 18 years&#xD;
&#xD;
          3. pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67&gt;20%);&#xD;
&#xD;
          4. No prior antitumor treatment with OXA, progress after first line chemotherapy with&#xD;
             platinum-based regimen. For recurrent patients after radical surgery, platinum-based&#xD;
             adjuvant chemotherapy should beyond 6 months prior to randomization;&#xD;
&#xD;
          5. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded)&#xD;
             (routine CT scan &gt;=20mm, spiral CT scan &gt;=10mm, no prior radiation to measurable&#xD;
             lesions);&#xD;
&#xD;
          6. Screening laboratory values must meet the following criteria (within past 7 days):&#xD;
             hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total&#xD;
             bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine&#xD;
             transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum&#xD;
             creatinine ≤1╳ULN;&#xD;
&#xD;
          7. KPS ≥ 70;&#xD;
&#xD;
          8. Predicted survival &gt;=3 months;&#xD;
&#xD;
          9. Negative serum or urine pregnant test within 7 days prior to randomization for&#xD;
             child-bearing age women;&#xD;
&#xD;
         10. Sexually active males or females willing to practice contraception during the study&#xD;
             until 30 days after end of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to OXA,5-HT3 receptor antagonists;&#xD;
&#xD;
          2. Prior antitumor therapy (including corticosteroids and immunotherapy) or participation&#xD;
             in other clinical trials within past 4 weeks, or have not recovered from toxicities&#xD;
             since the last treatment;&#xD;
&#xD;
          3. Received surgery within past 4 weeks, or have not recovered from surgery;&#xD;
&#xD;
          4. Severe diarrhea;&#xD;
&#xD;
          5. Concurrent severe infection；&#xD;
&#xD;
          6. Severe, uncontrolled medical condition that would affect patients' compliance or&#xD;
             obscure the interpretation of toxicity determination or adverse events, including&#xD;
             severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or&#xD;
             hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary&#xD;
             disease or symptomatic bronchospasm);&#xD;
&#xD;
          7. Prior long term steroid therapy (excluding short term steroid treatment which is&#xD;
             completed prior to &gt; 2 weeks of study enrollment)；&#xD;
&#xD;
          8. Meningeal carcinomatosis;&#xD;
&#xD;
          9. Patients with central nervous system(CNS) disorder or peripheral nervous system&#xD;
             disorder or psychiatric disease；&#xD;
&#xD;
         10. Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and&#xD;
             hypertension, or congestive heart failure, or cardiac infarction within 6 months prior&#xD;
             to study enrollment, or cardiac insufficiency；&#xD;
&#xD;
         11. Pregnant or nursing, or sexually active males or females refuse to practice&#xD;
             contraception during the study until 30 days after end of study;&#xD;
&#xD;
         12. History of other malignancy. However, subjects who have been disease-free for 5 years,&#xD;
             or subjects with a history of completely resected non-melanoma skin cancer or&#xD;
             successfully treated in situ carcinoma, are eligible；&#xD;
&#xD;
         13. Person with no capacity (legally) or inappropriate to continue study treatment for&#xD;
             ethics/medical reasons；&#xD;
&#xD;
         14. Underlying medical condition that, in the Investigator's opinion, would increase the&#xD;
             risks of study drug administration or obscure the interpretation of toxicity&#xD;
             determination or adverse events.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Shen</last_name>
      <phone>86-10-88196561</phone>
      <email>linshenpku@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Shen Lin</investigator_full_name>
    <investigator_title>MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>ORR</keyword>
  <keyword>OS</keyword>
  <keyword>PFS</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</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/NCT03279614
org study id: SOX-2
nct id: NCT03279614
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Currently, there is no standard second line treatment for patients with neuroendocrine
      carcinoma. SOX regimen has shown promising in previous study. The study was designed to
      confirm thet SOX regimen can be used as a second-line regimen for patients with advanced or
      metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with
      platinum based regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
description: CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation by RECIST 1.1
measure: Progression-free survival
time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
description: Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause
measure: Overall survival
time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
description: Overall survival is defined as the time from date of start of treatment to date of death due to any cause
measure: Incidence of Treatment-related Adverse Events （Safety and Tolerability）
time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
arm group label: SOX
arm group type: Experimental
description: OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W
intervention type: Drug
intervention name: SOX
description: OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W
arm group label: SOX
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Shen Lin
investigator title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
mesh term: Carcinoma
mesh term: Carcinoma, Neuroendocrine
sharing ipd: No