<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/NCT04457297</url>
  </required_header>
  <id_info>
    <org_study_id>EPOC 1905</org_study_id>
    <secondary_id>JapicCTI-205363</secondary_id>
    <nct_id>NCT04457297</nct_id>
  </id_info>
  <brief_title>Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection</brief_title>
  <acronym>ALTAIR</acronym>
  <official_title>A Randomized, Double-Blind, Phase III Study Comparing FTD/TPI Therapy Versus Placebo in Patients Who Are Positive for Blood Circulating Tumor DNA After Curative Resection of Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center Hospital East</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alpha-A, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cancer Center Hospital East</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is a randomized, double-blind, multinational Phase III study to evaluate the&#xD;
      efficacy and safety of preemptive treatment with FTD/TPI compared with administration of&#xD;
      placebo as follow-up, which is the standard of care, in patients who underwent curative&#xD;
      resection of colorectal cancer and then tested positive for ctDNA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival 1 (DFS1)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a secondary colorectal cancer lesion other than a relapse and death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Conversion to Negative ctDNA</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival 2 (DFS2)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a cancer lesion other than a relapse (secondary cancer), and death from any cause. In surviving subjects who have not been judged to have a relapse, the last date of survival with confirmation of no relapse be treated as the end of this period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The time from the date of enrollment to the date of death from any cause. In surviving subjects, the last date of confirmation of survival will be treated as the end of this period. In subjects lost to follow-up, the last date of confirmation of survival before loss to follow-up will be treated as the end of this period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>For each of the AEs due to the following study treatment, the frequency of cases with the worst grade in all courses according to CTCAE v5.0 will be calculated using all treated patients as the denominator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Completion Rate</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>This rate will be calculated for each eligible subject in accordance with the following equation. Treatment completion rate (%) = number of treatment courses completed/6 × 100</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Trifluridine and Tipiracil</condition>
  <condition>Circulating Tumor DNA</condition>
  <arm_group>
    <arm_group_label>trifluridine and tipiracil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>trifluridine and tipiracil</intervention_name>
    <description>Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.</description>
    <arm_group_label>trifluridine and tipiracil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have been histopathologically diagnosed with colorectal adenocarcinoma&#xD;
&#xD;
          2. Patients who have undergone radical curative resection of the primary and metastatic&#xD;
             tumors&#xD;
&#xD;
          3. Patients with colon or rectal cancer of Stage III based on final findings (T any N1/2&#xD;
             M0) (UICC TNM Classification, 8th Edition) who have a past history of standard&#xD;
             postoperative chemotherapy&#xD;
&#xD;
          4. Patients who tested positive for ctDNA using SignateraTM by an analysis of the latest&#xD;
             blood samples collected within 3 months prior to enrollment&#xD;
&#xD;
          5. Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans,&#xD;
             etc.&#xD;
&#xD;
          6. Patients who are capable of oral ingestion&#xD;
&#xD;
          7. Patients aged 20 years or older at the time of informed consent&#xD;
&#xD;
          8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of&#xD;
             0 or 1&#xD;
&#xD;
          9. Patients who have no severe disorder in major organs (such as the bone marrow, heart,&#xD;
             lungs, liver, and kidneys) and meet the following criteria (Data obtained most&#xD;
             recently and within 14 days of the date of enrollment will be used for enrollment.&#xD;
             Data obtained 2 weeks before the date of enrollment, on the same day of the week as&#xD;
             the enrollment date, may be used for enrollment.)&#xD;
&#xD;
               -  Neutrophil count ≥ 1,500/mm3&#xD;
&#xD;
               -  Platelet count ≥ 100,000/mm3&#xD;
&#xD;
               -  Hemoglobin ≥ 8.0 g/dL&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 mg/dL&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 mg/dL&#xD;
&#xD;
               -  ALT and AST ≤ 100 U/L&#xD;
&#xD;
         10. Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common&#xD;
             Terminology Criteria for Adverse Events (CTCAE) v5.0&#xD;
&#xD;
         11. Patients who voluntarily gave written consent to participate in the trial after&#xD;
             receiving a thorough explanation of the trial before enrolling in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of treatment with FTD/TPI&#xD;
&#xD;
          2. Patients with a history of treatment with 2 or more regimens of postoperative adjuvant&#xD;
             chemotherapy (Preoperative chemotherapy will not be counted as a regimen.)&#xD;
&#xD;
          3. Patients with a past history of a malignant tumor&#xD;
&#xD;
          4. Patients with a local or systemic active infection requiring intervention&#xD;
&#xD;
          5. Patients who are positive for HBs antigen or positive for HCV antibody&#xD;
&#xD;
          6. Patients who are positive for HIV antibody (Patients who have not been tested for HIV&#xD;
             antibody may be enrolled.)&#xD;
&#xD;
          7. Patients with poorly controlled infections or diabetes&#xD;
&#xD;
          8. Patients with a past history of interstitial lung diseases (such as interstitial&#xD;
             pneumonia and pulmonary fibrosis) requiring treatment or extensive findings of these&#xD;
             diseases on CT&#xD;
&#xD;
          9. Patients with a serious complication&#xD;
&#xD;
         10. Patients who have been receiving systemic administration (oral or intravenous) of&#xD;
             steroids (for 2 weeks or more at a dose of the equivalent of ≥ 10 mg/day of&#xD;
             prednisolone)&#xD;
&#xD;
         11. Patients for whom enrollment in the trial is difficult because of clinically&#xD;
             problematic psychiatric disorders&#xD;
&#xD;
         12. Pregnant or lactating women&#xD;
&#xD;
         13. Patients with reproductive potential who do not wish to use adequate contraceptive&#xD;
             measures during the period of participation in the trial and during the contraception&#xD;
             period&#xD;
&#xD;
         14. Patients who are judged by the attending physician to be ineligible for enrollment in&#xD;
             the trial for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Takayuki Yoshino, MD, PhD</last_name>
    <phone>+81-4-7133-1111</phone>
    <email>prj-altair_core@eps.co.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Toshiki Masuishi, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yoshiaki Nakamura, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Tomohiro Nishina, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital</name>
      <address>
        <city>Yoshida</city>
        <state>Fukui</state>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Takanori Goi, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Occupational and Environmental Health</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>807-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Keiji Hirata, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ichiro Takemasa, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yoshito Komatsu, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sano Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>655-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Masahito Kotaka, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Tsukuba Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki</state>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Toshikazu Moriwaki, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Keishi Nakamura, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital</name>
      <address>
        <city>Kita</city>
        <state>Kagawa</state>
        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Akihito Tsuji, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Marianna University School of Medicine Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>216-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yu Sunakawa, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jun Watanabe, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Manabu Shiozawa, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Masanobu Takahashi, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aizawa Hospital</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>390-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Masato Nakamura, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of the Ryukyus Hospital</name>
      <address>
        <city>Nakagami</city>
        <state>Okinawa</state>
        <zip>903-0215</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mitsuhisa Takatsuki, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shogen Boku, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mamoru Uemura, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Osaka Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Masahiro Gotou, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shimane Prefectural Central Hospital</name>
      <address>
        <city>Izumo</city>
        <state>Shimane</state>
        <zip>693-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Akiyoshi Kanazawa, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital</name>
      <address>
        <city>Bunkyo</city>
        <state>Tokyo</state>
        <zip>113-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kazushige Kawai, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Atsuo Takashima, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital Of JFCR</name>
      <address>
        <city>Koto</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kensei Yamaguchi, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Eiji Sunami</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Tadamichi Denda, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Masaru Morita, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Eiji Oki, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gifu University Hospital</name>
      <address>
        <city>Gifu</city>
        <zip>501-1194</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nobuhisa Matsuhashi, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hideki Ohdan, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yuji Miyamoto, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital, Kyoto Prefectural Univercity of Medicine</name>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yoshiaki Kuriu, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kyoto-Katsura Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>615-8256</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dai Manaka, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Fuminori Teraishi, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Osaka National Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>540-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Takeshi Kato, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Saitama</city>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hiroki Hara, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kentaro Yamazaki, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toyama University Hospital</name>
      <address>
        <city>Toyama</city>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shinya Kajiura, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100229</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kun-Huei Yeh, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center Hospital East</investigator_affiliation>
    <investigator_full_name>Takayuki Yoshino</investigator_full_name>
    <investigator_title>MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology</investigator_title>
  </responsible_party>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Gastrointestinal Neoplasms</keyword>
  <keyword>Digestive System Diseases</keyword>
  <keyword>Gastrointestinal Diseases</keyword>
  <keyword>Antineoplastic Agents</keyword>
  <keyword>trifluridine and tipiracil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trifluridine</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/NCT04457297
org study id: EPOC 1905
secondary id: JapicCTI-205363
nct id: NCT04457297
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial is a randomized, double-blind, multinational Phase III study to evaluate the
      efficacy and safety of preemptive treatment with FTD/TPI compared with administration of
      placebo as follow-up, which is the standard of care, in patients who underwent curative
      resection of colorectal cancer and then tested positive for ctDNA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Disease-free survival 1 (DFS1)
time frame: Up to 3 years
description: The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a secondary colorectal cancer lesion other than a relapse and death from any cause.
measure: Rate of Conversion to Negative ctDNA
time frame: Up to 2 years
description: This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.
measure: Disease-free survival 2 (DFS2)
time frame: Up to 3 years
description: The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a cancer lesion other than a relapse (secondary cancer), and death from any cause. In surviving subjects who have not been judged to have a relapse, the last date of survival with confirmation of no relapse be treated as the end of this period.
measure: Overall Survival (OS)
time frame: Up to 3 years
description: The time from the date of enrollment to the date of death from any cause. In surviving subjects, the last date of confirmation of survival will be treated as the end of this period. In subjects lost to follow-up, the last date of confirmation of survival before loss to follow-up will be treated as the end of this period.
measure: Incidence of Adverse Events
time frame: Up to 3 years
description: For each of the AEs due to the following study treatment, the frequency of cases with the worst grade in all courses according to CTCAE v5.0 will be calculated using all treated patients as the denominator.
measure: Treatment Completion Rate
time frame: Up to 3 years
description: This rate will be calculated for each eligible subject in accordance with the following equation. Treatment completion rate (%) = number of treatment courses completed/6 × 100
arm group label: trifluridine and tipiracil
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: trifluridine and tipiracil
description: Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
arm group label: trifluridine and tipiracil
intervention type: Drug
intervention name: Placebo
description: Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Takayuki Yoshino, MD, PhD
phone: +81-4-7133-1111
email: prj-altair_core@eps.co.jp
facility: 
status: Recruiting
investigator: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
investigator: 
country: Japan
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center Hospital East
investigator full name: Takayuki Yoshino
investigator title: MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Trifluridine