<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/NCT03788226</url>
  </required_header>
  <id_info>
    <org_study_id>FNF 014</org_study_id>
    <nct_id>NCT03788226</nct_id>
  </id_info>
  <brief_title>A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer</brief_title>
  <official_title>A Randomized Phase III Study Comparing POF (Paclitaxel/Oxaliplatin/Leucovorin/5-FU) With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Cancer Hospital</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>
      FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to&#xD;
      prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III&#xD;
      gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>3-year disease-free survival</measure>
    <time_frame>From enrollment to 5 years after treatment</time_frame>
    <description>The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>From enrollment to 5 years after treatment</time_frame>
    <description>The time from the date of randomisation to date of death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety (The incidence of chemotherapy related adverse events)</measure>
    <time_frame>From enrollment to 1 years after treatment</time_frame>
    <description>The incidence of chemotherapy related adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Gastric Cancer Stage III</condition>
  <arm_group>
    <arm_group_label>POF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAPOX/SOX/FOLFOX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.&#xD;
SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA &lt;1.25 40mg bid (total 80mg/day); BSA ≥1.25 - &lt;1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.&#xD;
mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>POF</intervention_name>
    <description>A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.</description>
    <arm_group_label>POF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAPOX/SOX/FOLFOX</intervention_name>
    <description>CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.&#xD;
SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA &lt;1.25 40mg bid (total 80mg/day); BSA ≥1.25 - &lt;1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.&#xD;
mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.</description>
    <arm_group_label>CAPOX/SOX/FOLFOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 70 years.&#xD;
&#xD;
          -  Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the&#xD;
             gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic&#xD;
             disease.&#xD;
&#xD;
          -  Subjects must be able to take orally.&#xD;
&#xD;
          -  R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined&#xD;
             to ensure adequate disease classification.&#xD;
&#xD;
          -  Previously untreated except for the initial gastric resection for the primary lesion.&#xD;
&#xD;
          -  ECOG performance status ≦ 1.&#xD;
&#xD;
          -  Able to start chemotherapy with 42 days after gastrectomy.&#xD;
&#xD;
          -  Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3&#xD;
&#xD;
          -  Creatine ≦ upper normal limit (UNL)&#xD;
&#xD;
          -  Total bilirubin ≦ 1.5 X UNL&#xD;
&#xD;
          -  AST, ALT and ALP ≦ 2.5 x UNL&#xD;
&#xD;
          -  Life expectancy estimated than 3 months&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active double cancer&#xD;
&#xD;
          -  Gastrointestinal bleeding&#xD;
&#xD;
          -  Pregnancy or lactation women, or women with suspected pregnancy or men with willing to&#xD;
             get pregnant&#xD;
&#xD;
          -  Definite contraindications for the use of corticosteroids&#xD;
&#xD;
          -  Any subject judged by the investigator to be unfit for any reason to participate in&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rongbo Lin</last_name>
    <phone>13705919382</phone>
    <phone_ext>13705919382</phone_ext>
    <email>rongbo_lin@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rongbo Lin</name>
      <address>
        <city>Fuzhou</city>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongbo Lin</last_name>
      <phone>13705919382</phone>
      <phone_ext>13705919382</phone_ext>
      <email>rongbo_lin@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>October 13, 2019</last_update_submitted>
  <last_update_submitted_qc>October 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2019</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>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03788226
org study id: FNF 014
nct id: NCT03788226
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to
      prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III
      gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year disease-free survival
time frame: From enrollment to 5 years after treatment
description: The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause
measure: overall survival
time frame: From enrollment to 5 years after treatment
description: The time from the date of randomisation to date of death from any cause
measure: safety (The incidence of chemotherapy related adverse events)
time frame: From enrollment to 1 years after treatment
description: The incidence of chemotherapy related adverse events
arm group label: POF
arm group type: Experimental
description: A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
arm group label: CAPOX/SOX/FOLFOX
arm group type: Active Comparator
description: CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.
SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.
mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.
intervention type: Drug
intervention name: POF
description: A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
arm group label: POF
intervention type: Drug
intervention name: CAPOX/SOX/FOLFOX
description: CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.
SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.
mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.
arm group label: CAPOX/SOX/FOLFOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rongbo Lin
phone: 13705919382
phone ext: 13705919382
email: rongbo_lin@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
sharing ipd: Undecided