<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/NCT01693432</url>
  </required_header>
  <id_info>
    <org_study_id>HMC-HO-GI-1202</org_study_id>
    <nct_id>NCT01693432</nct_id>
  </id_info>
  <brief_title>Docetaxel and S-1 for Advanced Esophageal Cancer</brief_title>
  <official_title>A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jeil Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hallym University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean&#xD;
      patients with esophageal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal cancer is the ninth most common cancer in male population in Korea. It was&#xD;
      estimated that 1,864 new cases of esophageal cancer were reported and 1,434 deaths occurred&#xD;
      in Korea in 2005.&#xD;
&#xD;
      Although half of the patients with esophageal cancer initially present with locoregional&#xD;
      disease amenable to radical surgery or radiation-based therapy, most patients eventually&#xD;
      develop metastatic disease with or without local recurrence.&#xD;
&#xD;
      Chemotherapy plays a major role in palliative therapy and remains to be the primary mode of&#xD;
      treatment for the recurrent or metastatic esophageal cancer. Although various chemotherapy&#xD;
      regimens are available, esophageal cancer carries a very poor prognosis, with a mean survival&#xD;
      time of less than 8.1 months with current chemotherapies used singly or in combination with&#xD;
      5-fluorouracil (5-FU), vindesine, mitomycin, docetaxel, paclitaxel, cisplatin, irinotecan,&#xD;
      vinorelbine, or capecitabine. The majority of the trials performed were in small numbers of&#xD;
      patients with reported response rates from 15 to 40%.&#xD;
&#xD;
      The response was usually of short duration and there was no survival benefit with single&#xD;
      agent chemotherapy. Combination chemotherapy has slightly improved the results in terms of&#xD;
      duration of response (3-6 months), but still there was little improvement in overall&#xD;
      survival. Therefore, the identification of new active agents is essential to prolong the&#xD;
      survival.&#xD;
&#xD;
      Clinical trials of single agent docetaxel have been reported in patients with esophageal&#xD;
      cancer and the response rate is about 18-25%.&#xD;
&#xD;
      S-1, a new biochemical modulator of 5-FU, is an oral dihydropyrimidine dehydrogenase(DPD)&#xD;
      inhibitory fluoropyrimidine. The advantages of S-1 compared with 5-FU are greater convenience&#xD;
      because of its oral formulation and continuous delivery, without intravenous infusion. S-1 is&#xD;
      frequently used as a substitute for 5-FU in gastric cancer, but limited data is available for&#xD;
      esophageal cancer.&#xD;
&#xD;
      The combination of docetaxel and S-1 is highly active and well tolerated in advanced or&#xD;
      recurrent gastric cancer, and the synergistic antitumor activity has been fully elucidated.&#xD;
&#xD;
      Therefore, we will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in&#xD;
      Korean patients with esophageal cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Objective response rate</measure>
    <time_frame>1.5 years</time_frame>
    <description>Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>1.5 years</time_frame>
    <description>Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1.5 years</time_frame>
    <description>Overall survival time will be measured from the start of study treatment until death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity profiles</measure>
    <time_frame>1.5 years</time_frame>
    <description>adverse events will be descripted and graded using NCI-CTCAE version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>1.5 years</time_frame>
    <description>Disease control rate will be measured from the rate of complete response (disappearance of disease), partial response (decrease at least 30% in the sum of the longest diameters of target lesions), and stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) by RECIST (response evaluation criteria in solid tumors) guidelines.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <arm_group>
    <arm_group_label>DS (docetaxel+S-1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment will be delivered as a 3-week cycle.&#xD;
Docetaxel 60 mg/m²IV on day 1&#xD;
S-1 80 mg/m2/day PO on day 1-14</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS (docetaxel+S-1)</intervention_name>
    <description>Treatment will be delivered as a 3-week cycle.&#xD;
Docetaxel 60 mg/m²IV on day 1&#xD;
S-1 80 mg/m2/day PO on day 1-14</description>
    <arm_group_label>DS (docetaxel+S-1)</arm_group_label>
    <other_name>Taxotere</other_name>
    <other_name>TS-1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus.&#xD;
&#xD;
          -  Unresectable locally advanced, recurrent or metastatic disease.&#xD;
&#xD;
          -  Measurable or evaluable disease by RECIST criteria 1.1.&#xD;
&#xD;
          -  Minimum age of 18 years.&#xD;
&#xD;
          -  ECOG Performance status 0-2.&#xD;
&#xD;
          -  Prior chemotherapy is not allowed.&#xD;
&#xD;
          -  More than 4 weeks since completion of prior radiotherapy (measurable or evaluable&#xD;
             lesions are outside the radiation field)&#xD;
&#xD;
          -  Adequate organ functions&#xD;
&#xD;
          -  Patients must sign an informed consent indicating that they are aware of the&#xD;
             investigational nature of the study in keeping with the policy of the hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other tumor type than squamous cell carcinoma and adenocarcinoma&#xD;
&#xD;
          -  Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without&#xD;
             docetaxel and S-1&#xD;
&#xD;
          -  Obvious bowel obstruction unrelieved by proper management&#xD;
&#xD;
          -  Evidence of serious gastrointestinal bleeding&#xD;
&#xD;
          -  Patients with CNS metastases&#xD;
&#xD;
          -  Patients with active infection, severe heart disease, uncontrollable hypertension or&#xD;
             diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or&#xD;
             breast feeding&#xD;
&#xD;
          -  Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ&#xD;
             cancer of uterine cervix&#xD;
&#xD;
          -  Known history of cerebral or leptomeningeal metastases or neurologic disease&#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>Dae Young Zang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dae Young Zang, MD, PhD</last_name>
    <phone>82313803871</phone>
    <email>fhdzang@hallym.or.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jin Hee Jung, RN</last_name>
    <phone>82313803704</phone>
    <email>jhjung23@daum.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hallym University Medical Center</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dae Young Zang, MD, PhD</last_name>
      <phone>82313803871</phone>
      <email>fhdzang@hallym.or.kr</email>
    </contact>
    <contact_backup>
      <last_name>Jin Hee Jung, RN</last_name>
      <phone>82313803704</phone>
      <email>jhjung23@daum.net</email>
    </contact_backup>
    <investigator>
      <last_name>Hyeong Su Kim, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Boram Han, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Esophageal neoplasms</keyword>
  <keyword>Docetaxel</keyword>
  <keyword>S-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
  </intervention_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/NCT01693432
org study id: HMC-HO-GI-1202
nct id: NCT01693432
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean
      patients with esophageal cancer.
Esophageal cancer is the ninth most common cancer in male population in Korea. It was
      estimated that 1,864 new cases of esophageal cancer were reported and 1,434 deaths occurred
      in Korea in 2005.

      Although half of the patients with esophageal cancer initially present with locoregional
      disease amenable to radical surgery or radiation-based therapy, most patients eventually
      develop metastatic disease with or without local recurrence.

      Chemotherapy plays a major role in palliative therapy and remains to be the primary mode of
      treatment for the recurrent or metastatic esophageal cancer. Although various chemotherapy
      regimens are available, esophageal cancer carries a very poor prognosis, with a mean survival
      time of less than 8.1 months with current chemotherapies used singly or in combination with
      5-fluorouracil (5-FU), vindesine, mitomycin, docetaxel, paclitaxel, cisplatin, irinotecan,
      vinorelbine, or capecitabine. The majority of the trials performed were in small numbers of
      patients with reported response rates from 15 to 40%.

      The response was usually of short duration and there was no survival benefit with single
      agent chemotherapy. Combination chemotherapy has slightly improved the results in terms of
      duration of response (3-6 months), but still there was little improvement in overall
      survival. Therefore, the identification of new active agents is essential to prolong the
      survival.

      Clinical trials of single agent docetaxel have been reported in patients with esophageal
      cancer and the response rate is about 18-25%.

      S-1, a new biochemical modulator of 5-FU, is an oral dihydropyrimidine dehydrogenase(DPD)
      inhibitory fluoropyrimidine. The advantages of S-1 compared with 5-FU are greater convenience
      because of its oral formulation and continuous delivery, without intravenous infusion. S-1 is
      frequently used as a substitute for 5-FU in gastric cancer, but limited data is available for
      esophageal cancer.

      The combination of docetaxel and S-1 is highly active and well tolerated in advanced or
      recurrent gastric cancer, and the synergistic antitumor activity has been fully elucidated.

      Therefore, we will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in
      Korean patients with esophageal cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: 1.5 years
description: Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.
measure: Progression free survival
time frame: 1.5 years
description: Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause
measure: Overall survival
time frame: 1.5 years
description: Overall survival time will be measured from the start of study treatment until death due to any cause
measure: Toxicity profiles
time frame: 1.5 years
description: adverse events will be descripted and graded using NCI-CTCAE version 4.0
measure: Disease control rate
time frame: 1.5 years
description: Disease control rate will be measured from the rate of complete response (disappearance of disease), partial response (decrease at least 30% in the sum of the longest diameters of target lesions), and stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) by RECIST (response evaluation criteria in solid tumors) guidelines.
arm group label: DS (docetaxel+S-1)
arm group type: Experimental
description: Treatment will be delivered as a 3-week cycle.
Docetaxel 60 mg/m²IV on day 1
S-1 80 mg/m2/day PO on day 1-14
intervention type: Drug
intervention name: DS (docetaxel+S-1)
description: Treatment will be delivered as a 3-week cycle.
Docetaxel 60 mg/m²IV on day 1
S-1 80 mg/m2/day PO on day 1-14
arm group label: DS (docetaxel+S-1)
other name: Taxotere
other name: TS-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dae Young Zang, MD, PhD
role: Principal Investigator
affiliation: Hallym University Medical Center
last name: Dae Young Zang, MD, PhD
phone: 82313803871
email: fhdzang@hallym.or.kr
last name: Jin Hee Jung, RN
phone: 82313803704
email: jhjung23@daum.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Docetaxel
sharing ipd: Undecided