<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/NCT02205008</url>
  </required_header>
  <id_info>
    <org_study_id>EPIC-GC</org_study_id>
    <secondary_id>KNUMCGCC-001</secondary_id>
    <nct_id>NCT02205008</nct_id>
  </id_info>
  <brief_title>Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer</brief_title>
  <acronym>EPIC-GC</acronym>
  <official_title>Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yeungnam University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Catholic University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dong-A University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea Cancer Center Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate&#xD;
      intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although&#xD;
      we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal&#xD;
      chemotherapy have been published.&#xD;
&#xD;
      In this study, we review the clinicopathological characteristics of patients and effects of&#xD;
      early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric&#xD;
      cancer-specific survival and patterns of recurrence of gastric cancer patients with&#xD;
      macroscopic serosal invasion.&#xD;
&#xD;
      The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall&#xD;
      and disease free survival of advanced gastric cancer patients with serosal invasion after&#xD;
      potentially curative surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>relapsed free survival</measure>
    <time_frame>postoperative 3 years</time_frame>
    <description>during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>postoperative 5 years</time_frame>
    <description>during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded</description>
  </secondary_outcome>
  <other_outcome>
    <measure>surgery and intraperitoneal chemotherapy-related morbidity and mortality</measure>
    <time_frame>postoperative 30days</time_frame>
    <description>In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Advanced Gastric Cancer With Serosal Invasion</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery</intervention_name>
    <description>Total or subtotal gastrectomy with D2</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>adjuvant systemic chemotherapy</intervention_name>
    <description>adjuvant systemic chemotherapy with S-1 (&lt;1.25m2:40mg, 1.25-1.5m2:50mg, &gt;1.5m2:60mg, bid)</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Early postoperative intraperitoneal chemothgerapy</intervention_name>
    <description>operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2&#xD;
1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. histologically proven adenocarcinoma of the stomach&#xD;
&#xD;
          2. preoperative suspicion of serosal invasion on the radiological examination&#xD;
&#xD;
          3. candidate for curative resection of the stomach with D2&#xD;
&#xD;
          4. age from 19 to 70 year old&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group Performance status :0, 1, or 2&#xD;
&#xD;
          6. absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and&#xD;
             platelet≥100,000/microliter&#xD;
&#xD;
          7. serum Creatinine&lt;1.5mg/dL&#xD;
&#xD;
          8. total bilirubin &lt;2 x upper normal limit, transaminase&lt;3 x upper normal limit&#xD;
&#xD;
          9. patients without previous administration of chemotherapeutic agent&#xD;
&#xD;
         10. patients who agreed and signed to the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. malignancy of the stomach except for adenocarcinoma&#xD;
&#xD;
          2. history of hypersensitivity to 5-fluorouracil or mitomycin&#xD;
&#xD;
          3. concomitant infectious disease&#xD;
&#xD;
          4. active hepatitis or chronic liver disease&#xD;
&#xD;
          5. history of psychotic disorders&#xD;
&#xD;
          6. patients with disorders in the central nervous system&#xD;
&#xD;
          7. history of other malignancy within 5 years&#xD;
&#xD;
          8. history of clinically significant heart disease (congestive heart failure, symptomatic&#xD;
             coronary artery disease, symptomatic arrhythmia, myocardial infarction)&#xD;
&#xD;
          9. patients with increased bleeding tendency&#xD;
&#xD;
         10. pregnant or lactating female patients&#xD;
&#xD;
         11. patient who did not agreed and signed to the informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wansik Yu, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wansik Yu, MD, PhD, FACS</last_name>
    <phone>82-53-200-2700</phone>
    <email>wyu@knu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kyungpook National University Medical Center Gastric Cancer Center</name>
      <address>
        <city>Daegu</city>
        <zip>702-210</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wansik Yu, MD, PhD</last_name>
      <phone>82-53-200-2700</phone>
      <email>wyu@nknu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Wansik Yu, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oh Kyoung Kwon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>1. Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg 1987;11:418-425. 2. Lee JL, Kang HJ, Kang YK, et al. Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurent gastric cancer. Cancer Chemother Pharmacol 2007 (E-pub). 3. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drug 2004;15:85-106. 4. Sugimachi K, Maehara Y, Horikoshi N et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210. 5. Koizumi W, Kurihara M, Nakajo S et al. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-197. 6. Sakata Y, Ohtsu A, Horikoshi N et al. Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720. 7. Nagashima F, Ohtsu A, Yoshida S et al. Japanese nationwide postmarketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 2005;8:6-11. 8. Chollet P, Schoffski P, Weigang-Kohler K et al. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC early clinical studies group (ECGC). Eur J Cancer 2003;39:1264-1270. 9. Ilson D. Just when you thought the fluorouracil debate was over: S-1 and gastric cancer. J Clin Oncol 2005;23:6826-6828. 10. Hoff PM, Saad ED, Ajani JA et al. Phase I study with pharmacokinetics of S-1, an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134-142. 11. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989;10:1-10.</citation>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Wansik Yu</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>advanced gastric cancer</keyword>
  <keyword>serosal invasion</keyword>
  <keyword>peritoneal recurrence</keyword>
  <keyword>intraperitoneal chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02205008
org study id: EPIC-GC
secondary id: KNUMCGCC-001
nct id: NCT02205008
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate
      intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although
      we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal
      chemotherapy have been published.

      In this study, we review the clinicopathological characteristics of patients and effects of
      early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric
      cancer-specific survival and patterns of recurrence of gastric cancer patients with
      macroscopic serosal invasion.

      The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall
      and disease free survival of advanced gastric cancer patients with serosal invasion after
      potentially curative surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: relapsed free survival
time frame: postoperative 3 years
description: during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
measure: overall survival
time frame: postoperative 5 years
description: during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
measure: surgery and intraperitoneal chemotherapy-related morbidity and mortality
time frame: postoperative 30days
description: In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy.
arm group label: Arm A
arm group type: Active Comparator
description: curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
arm group label: Arm B
arm group type: Placebo Comparator
description: curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
intervention type: Procedure
intervention name: surgery
description: Total or subtotal gastrectomy with D2
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: adjuvant systemic chemotherapy
description: adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid)
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Early postoperative intraperitoneal chemothgerapy
description: operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2
1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq
arm group label: Arm A
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wansik Yu, MD. PhD
role: Principal Investigator
affiliation: Kyungpook National University Medical Center
last name: Wansik Yu, MD, PhD, FACS
phone: 82-53-200-2700
email: wyu@knu.ac.kr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Korea, Republic of
citation: 1. Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg 1987;11:418-425. 2. Lee JL, Kang HJ, Kang YK, et al. Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurent gastric cancer. Cancer Chemother Pharmacol 2007 (E-pub). 3. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drug 2004;15:85-106. 4. Sugimachi K, Maehara Y, Horikoshi N et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210. 5. Koizumi W, Kurihara M, Nakajo S et al. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-197. 6. Sakata Y, Ohtsu A, Horikoshi N et al. Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720. 7. Nagashima F, Ohtsu A, Yoshida S et al. Japanese nationwide postmarketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 2005;8:6-11. 8. Chollet P, Schoffski P, Weigang-Kohler K et al. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC early clinical studies group (ECGC). Eur J Cancer 2003;39:1264-1270. 9. Ilson D. Just when you thought the fluorouracil debate was over: S-1 and gastric cancer. J Clin Oncol 2005;23:6826-6828. 10. Hoff PM, Saad ED, Ajani JA et al. Phase I study with pharmacokinetics of S-1, an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134-142. 11. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989;10:1-10.
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Wansik Yu
investigator title: professor
mesh term: Stomach Neoplasms