<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/NCT01732380</url>
  </required_header>
  <id_info>
    <org_study_id>1stPeopleLianyungang</org_study_id>
    <nct_id>NCT01732380</nct_id>
  </id_info>
  <brief_title>A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer</brief_title>
  <official_title>A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First People's Hospital of Lianyungang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The East Hospital of Lianyungang</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Donghai People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Ganyu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First People's Hospital of Lianyungang</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus&#xD;
      radiotherapy in subjects with inoperable esophageal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy&#xD;
      (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5&#xD;
      times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in&#xD;
      subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks&#xD;
      unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months&#xD;
      .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival,&#xD;
      toxicity of the therapy are other second endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>Phase 2</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>Progression-Free-Survival</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 2 years</time_frame>
    <description>People in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival is often stated as a five-year survival, which means people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Inoperable Esophageal Cancer Stage I-III</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Raltitrexed/Oxaliplatin Plus Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raltitrexed</intervention_name>
    <arm_group_label>Raltitrexed/Oxaliplatin Plus Radiotherapy</arm_group_label>
    <other_name>TOMUDEX</other_name>
    <other_name>Sai Wei Jian</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <arm_group_label>Raltitrexed/Oxaliplatin Plus Radiotherapy</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_label>Raltitrexed/Oxaliplatin Plus Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)&#xD;
&#xD;
          -  Measurable disease according to RECIST criteria&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  WHO performance score &lt; 2&#xD;
&#xD;
          -  Estimated life expectancy of &gt; 12 weeks&#xD;
&#xD;
          -  Subjects will be considered appropriate to receive systemic chemotherapy and pelvic&#xD;
             radiotherapy&#xD;
&#xD;
          -  Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL&#xD;
&#xD;
          -  Renal function: Cr ≤ 1.25×UNL&#xD;
&#xD;
          -  Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL&#xD;
&#xD;
          -  Documented informed consent to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with distant metastases&#xD;
&#xD;
          -  Pregnancy or breast feeding. Women of childbearing age must use effective&#xD;
             contraception&#xD;
&#xD;
          -  Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia,&#xD;
             unstable angina, myocardial infarction, serious heart valve disease, resistant&#xD;
             hypertension)&#xD;
&#xD;
          -  Evidence of bleeding diathesis or serious infection&#xD;
&#xD;
          -  pregnant or lactating woman&#xD;
&#xD;
          -  Patient participation in other studies&#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>Xiaodong Jiang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>The First People's Hospital of Lianyungang</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaodong Jiang, Doctor</last_name>
    <phone>86-0518-85469074</phone>
    <email>jxdysy1970@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First People's Hospital of Lianyungang</name>
      <address>
        <city>Lianyungang</city>
        <state>Jiangsu</state>
        <zip>222002</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaodong Jiang, Doctor</last_name>
      <email>jxdysy1970@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Courrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175.</citation>
    <PMID>20645400</PMID>
  </reference>
  <reference>
    <citation>Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.</citation>
    <PMID>17329193</PMID>
  </reference>
  <reference>
    <citation>McKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14.</citation>
    <PMID>20839062</PMID>
  </reference>
  <reference>
    <citation>Seitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183.</citation>
    <PMID>12176786</PMID>
  </reference>
  <reference>
    <citation>Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.</citation>
    <PMID>12075739</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</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>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Raltitrexed</mesh_term>
  </intervention_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/NCT01732380
org study id: 1stPeopleLianyungang
nct id: NCT01732380
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus
      radiotherapy in subjects with inoperable esophageal cancer.
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy
      (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5
      times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in
      subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks
      unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months
      .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival,
      toxicity of the therapy are other second endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free-Survival
time frame: up to 2 years
description: Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
measure: Response Rate
time frame: up to 2 years
description: Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.
measure: Overall survival
time frame: up to 2 years
description: People in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival is often stated as a five-year survival, which means people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.
arm group label: Radiotherapy
arm group type: Active Comparator
description: Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy
arm group type: Experimental
description: Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
intervention type: Drug
intervention name: Raltitrexed
arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy
other name: TOMUDEX
other name: Sai Wei Jian
intervention type: Drug
intervention name: Oxaliplatin
arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy
other name: Eloxatin
intervention type: Radiation
intervention name: Radiotherapy
arm group label: Radiotherapy
arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaodong Jiang, Doctor
role: Study Chair
affiliation: The First People's Hospital of Lianyungang
last name: Xiaodong Jiang, Doctor
phone: 86-0518-85469074
email: jxdysy1970@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Courrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175.
PMID: 20645400
citation: Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.
PMID: 17329193
citation: McKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14.
PMID: 20839062
citation: Seitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183.
PMID: 12176786
citation: Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.
PMID: 12075739
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Oxaliplatin
mesh term: Raltitrexed