<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/NCT04416490</url>
  </required_header>
  <id_info>
    <org_study_id>BR-OXP-OS-401</org_study_id>
    <nct_id>NCT04416490</nct_id>
  </id_info>
  <brief_title>Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer</brief_title>
  <acronym>OCEAN</acronym>
  <official_title>A Prospective Observational Study to Investigate Patients' Prognosis and Patterns of Adjuvant Chemotherapy Use After Curative Resection of Primary Colon Cancer at High-risk Stage II or Stage III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boryung Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</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>
      According to general medical guidelines, adjuvant chemotherapy is used after curative&#xD;
      resection of high-risk stage II or III primary colon cancer. However, there exist limitations&#xD;
      using clinical trial data acquired from highly selected subjects in a controlled environment.&#xD;
      For example, patients aged over 70 years old were in many cases excluded from clinical trials&#xD;
      resulting in insufficient data on the efficacy of therapies including oxaliplatin in aged&#xD;
      patients, and the source data of the medical guidelines did not fully reflect the conditions&#xD;
      of Korean patients. In addition, suggestions are continuously being submitted for existing&#xD;
      therapies with modified administration periods and methods with the aim to search for the&#xD;
      optimum effect over side effects. Discussions are also held on meta analyses results that&#xD;
      imply the need to apply slightly different approaches through small groups of patient and&#xD;
      disease factors. As there are more diverse adjuvant therapy protocols that can be applied to&#xD;
      post-surgery colon cancer patients, it is necessary to figure out the patterns of adjuvant&#xD;
      chemotherapies actually used in Korean medical practices. Also, in order to complement the&#xD;
      limitation of external validity of the existing base clinical data, a multifaceted&#xD;
      exploratory analysis will be conducted by making follow-up observations on patterns,&#xD;
      prognosis results, quality of life, adverse effects, etc. of post-surgery adjuvant&#xD;
      chemotherapies actually used in around 30 sites in Korea under the noninterventional&#xD;
      observational study conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [Overview] Investigators will obtain voluntary consent for participation in this study from&#xD;
      patients with high-risk stage II or stage III colon cancer who require or are planning to&#xD;
      receive adjuvant chemotherapy after curative resection. Patients who provided written consent&#xD;
      for using their personal information and who satisfy inclusion/exclusion criteria will be&#xD;
      given a study enrollment number. Among the predefined study-relevant data, available data on&#xD;
      these patients will be collected in the case report forms (CRF) until the study is completed.&#xD;
&#xD;
      [Follow-up observation schedule and the scope of data collection] Since this study is an&#xD;
      observational study, data collection in the CRF will be restricted to the data created only&#xD;
      from usual treatment practices and there will be no separate test or additional drug&#xD;
      administration for the study. However, subjects will be asked to complete questionnaire to&#xD;
      evaluate their quality of life at the following time points: baseline, Month 3 (13 weeks ± 2&#xD;
      weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8&#xD;
      weeks), Month 36 (156 weeks ± 8 weeks). For subjects who drop out from the study or in case&#xD;
      of disease event (relapse, metastasis or new primary malignant tumor), the questionnaire will&#xD;
      be conducted at the time of drop-out or disease event. Survival of all subjects (including&#xD;
      those who drop out from the study or whose disease event is confirmed) will be checked every&#xD;
      6 months after adjuvant chemotherapy started. Among the data created from the subjects on&#xD;
      their visits for treatment, the following data will be collected for the purpose of this&#xD;
      study.&#xD;
&#xD;
        -  Demographics of the subjects.&#xD;
&#xD;
        -  Colon cancer information (diagnosis information, risk factors, surgery information).&#xD;
&#xD;
        -  Whether or not neoadjuvant chemotherapy was conducted.&#xD;
&#xD;
        -  Underlying disease.&#xD;
&#xD;
        -  Adjuvant chemotherapy information.&#xD;
&#xD;
        -  Other concomitant medication (drugs administered for prevention and treatment of OXLIPN,&#xD;
           drugs administered for treatment of Grade 3-4 adverse drug reactions/serious adverse&#xD;
           drug reactions related to the chemotherapy).&#xD;
&#xD;
        -  Vital signs, height, and weight.&#xD;
&#xD;
        -  Performance Status evaluation (ECOG PS).&#xD;
&#xD;
        -  Geriatric Assessment (KG-7): for subjects ≥ 65 years old.&#xD;
&#xD;
        -  Quality of Life assessment (FACT-C, FACT/GOG-NTX-12).&#xD;
&#xD;
        -  Laboratory test results.&#xD;
&#xD;
        -  Tumor Marker (CEA, CA 19-9) test results.&#xD;
&#xD;
        -  Molecular genetic test results (MSI [microsatellite instability] and/or MMR [DNA&#xD;
           mismatch repair gene], immunohistochemistry test for protein, KRAS, NRAS, BRAF etc.).&#xD;
&#xD;
        -  Colonoscopy/CT results.&#xD;
&#xD;
        -  Disease event (relapse, metastasis or new primary malignant tumor).&#xD;
&#xD;
        -  Survival of subjects.&#xD;
&#xD;
        -  Oxaliplatin-induced Peripheral Neuropathy (OXLIPN): Only when oxaliplatin is&#xD;
           administered.&#xD;
&#xD;
        -  Grade 3-4 adverse drug reactions related to chemotherapy (based on CTCAE v.5.0).&#xD;
&#xD;
        -  Serious adverse drug reactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 25, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Type of adjuvant chemotherapy</measure>
    <time_frame>through adjuvant chemotherapies completion, an average of 24 weeks</time_frame>
    <description>Type of adjuvant chemotherapy that were used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of adjuvant chemotherapy</measure>
    <time_frame>through adjuvant chemotherapies completion, an average of 12 cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days)</time_frame>
    <description>Frequency of adjuvant chemotherapy that were used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Free Survival (DFS)</measure>
    <time_frame>From date of resection surgery until the date of first documented progression, assessed up to 36 months</time_frame>
    <description>Time from the date of resection surgery to the date of first relapse,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of resection surgery until the date of death, assessed up to 36 months</time_frame>
    <description>Time from the date of resection surgery to the date of death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Whether locally relapsed, whether metastasis is present, location of metastasis, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment (FACT-C)</measure>
    <time_frame>Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Subjects will be asked to complete questionnaires to evaluate their quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment (FACT/GOG-NTX-12)</measure>
    <time_frame>Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Subjects will be asked to complete questionnaires to evaluate their quality of life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse drug reactions/serious adverse drug reactions</measure>
    <time_frame>From the date of adjuvant chemotherapy started until the end of follow-up(36 month)</time_frame>
    <description>Overall incidence of grade 3-4 adverse drug reactions/serious adverse drug reactions</description>
  </other_outcome>
  <other_outcome>
    <measure>Oxaliplatin Induced Peripheral Neuropathy, OXLIPN</measure>
    <time_frame>From the date of adjuvant chemotherapy started until the end of follow-up(36 month)</time_frame>
    <description>Overall incidence of Oxaliplatin Induced Peripheral Neuropathy, OXLIPN</description>
  </other_outcome>
  <other_outcome>
    <measure>Performance Status (ECOG) evaluation results</measure>
    <time_frame>Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Frequency and ratio of ECOG evaluation results will be presented by time point.</description>
  </other_outcome>
  <other_outcome>
    <measure>Results on weight</measure>
    <time_frame>Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Descriptive statistics will be presented for the results of weight by time point.</description>
  </other_outcome>
  <other_outcome>
    <measure>Results on body temperature</measure>
    <time_frame>Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Descriptive statistics will be presented for the results of body temperature by time point.</description>
  </other_outcome>
  <other_outcome>
    <measure>Results on pulse</measure>
    <time_frame>Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Descriptive statistics will be presented for the results of pulse by time point.</description>
  </other_outcome>
  <other_outcome>
    <measure>Results on blood pressure</measure>
    <time_frame>Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)</time_frame>
    <description>Descriptive statistics will be presented for the results of blood pressure by time point.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Stage II Colon Cancer</condition>
  <condition>Stage III Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with high-risk stage II or stage III primary colon cancer who have received curative resection</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with high-risk stage II or stage III primary colon cancer who have received&#xD;
        curative resection. Approximately 2,000 subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects are given explanations about the study objectives and methods, and will&#xD;
             express their consent by signing a written agreement to use their personal&#xD;
             information.&#xD;
&#xD;
          2. Male and female adult subjects who are ≥ 19 years old.&#xD;
&#xD;
          3. Subjects are confirmed to have primary colon cancer through histological diagnosis and&#xD;
             are at *high-risk stage II (T3/4, N0M0) or stage III (any T, N1/2, M0).&#xD;
&#xD;
               -  High-risk stage II is determined when one or more of the following are&#xD;
                  applicable.&#xD;
&#xD;
                    1. Cancer is at T4 stage (stage IIB,IIC);&#xD;
&#xD;
                    2. Cancer cell differentiation grade is 3 or 4 (poor histologic grade);&#xD;
&#xD;
                    3. Cancer cells are present in lymphatic or blood vessels around the tumor&#xD;
                       (peritumoral lymphovascular involvement);&#xD;
&#xD;
                    4. Ileus was present during surgery (bowel obstruction at presentation);&#xD;
&#xD;
                    5. Cancer is at T3 stage with localized perforation or there are indeterminate&#xD;
                       cancer cells residual on the incisal surface. (T3 lesions with localized&#xD;
                       perforation or close, indeterminate, or positive margins); or,&#xD;
&#xD;
                    6. Cancer cells invaded into the area around the ganglion (perineural&#xD;
                       invasion).&#xD;
&#xD;
          4. Subjects are decided to require adjuvant chemotherapy including oxaliplatin and/or&#xD;
             capecitabine after curative resection (E.g.: FOLFOX, CapeOx or Capecitabine and&#xD;
             modified therapies).&#xD;
&#xD;
          5. Subjects' performance status score (ECOG PS) is 2 or lower (0, 1, 2).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects are diagnosed with other primary cancers that can influence the treatment or&#xD;
             prognosis of primary rectal and colon cancers.&#xD;
&#xD;
          2. Subjects are diagnosed with relapsed or secondary colon cancer.&#xD;
&#xD;
          3. Subjects with Stage 0/1 (Tis/1/2, N0M0) or Stage IV (any T, any N, M1) colon cancer.&#xD;
&#xD;
          4. Subjects who are currently on adjuvant chemotherapy after curative resection.&#xD;
&#xD;
          5. Subjects who are receiving palliative chemotherapy.&#xD;
&#xD;
          6. Pregnant and breast-feeding subjects.&#xD;
&#xD;
          7. Subjects who are currently participating in other clinical trials (clinical trials for&#xD;
             drugs or medical devices) or are planning to participate in other clinical trials&#xD;
             during the duration of this study. However, subjects participating in a&#xD;
             noninterventional observational study or a registry study can participate in this&#xD;
             study.&#xD;
&#xD;
          8. Other subjects who are not suitable for study participation upon the investigator's&#xD;
             decision.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myung Sook Hong</last_name>
    <role>Study Director</role>
    <affiliation>Boryung Pharmaceutical Co., Ltd</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Myung Sook Hong</last_name>
    <phone>82-2-708-8238</phone>
    <email>mshong@boryung.co.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei University Health System, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joong-Bae Ahn, M.D., Ph.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colon cancer</keyword>
  <keyword>high-risk stage</keyword>
  <keyword>curative resection</keyword>
  <keyword>adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT04416490
org study id: BR-OXP-OS-401
nct id: NCT04416490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
According to general medical guidelines, adjuvant chemotherapy is used after curative
      resection of high-risk stage II or III primary colon cancer. However, there exist limitations
      using clinical trial data acquired from highly selected subjects in a controlled environment.
      For example, patients aged over 70 years old were in many cases excluded from clinical trials
      resulting in insufficient data on the efficacy of therapies including oxaliplatin in aged
      patients, and the source data of the medical guidelines did not fully reflect the conditions
      of Korean patients. In addition, suggestions are continuously being submitted for existing
      therapies with modified administration periods and methods with the aim to search for the
      optimum effect over side effects. Discussions are also held on meta analyses results that
      imply the need to apply slightly different approaches through small groups of patient and
      disease factors. As there are more diverse adjuvant therapy protocols that can be applied to
      post-surgery colon cancer patients, it is necessary to figure out the patterns of adjuvant
      chemotherapies actually used in Korean medical practices. Also, in order to complement the
      limitation of external validity of the existing base clinical data, a multifaceted
      exploratory analysis will be conducted by making follow-up observations on patterns,
      prognosis results, quality of life, adverse effects, etc. of post-surgery adjuvant
      chemotherapies actually used in around 30 sites in Korea under the noninterventional
      observational study conditions.
[Overview] Investigators will obtain voluntary consent for participation in this study from
      patients with high-risk stage II or stage III colon cancer who require or are planning to
      receive adjuvant chemotherapy after curative resection. Patients who provided written consent
      for using their personal information and who satisfy inclusion/exclusion criteria will be
      given a study enrollment number. Among the predefined study-relevant data, available data on
      these patients will be collected in the case report forms (CRF) until the study is completed.

      [Follow-up observation schedule and the scope of data collection] Since this study is an
      observational study, data collection in the CRF will be restricted to the data created only
      from usual treatment practices and there will be no separate test or additional drug
      administration for the study. However, subjects will be asked to complete questionnaire to
      evaluate their quality of life at the following time points: baseline, Month 3 (13 weeks ± 2
      weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8
      weeks), Month 36 (156 weeks ± 8 weeks). For subjects who drop out from the study or in case
      of disease event (relapse, metastasis or new primary malignant tumor), the questionnaire will
      be conducted at the time of drop-out or disease event. Survival of all subjects (including
      those who drop out from the study or whose disease event is confirmed) will be checked every
      6 months after adjuvant chemotherapy started. Among the data created from the subjects on
      their visits for treatment, the following data will be collected for the purpose of this
      study.

        -  Demographics of the subjects.

        -  Colon cancer information (diagnosis information, risk factors, surgery information).

        -  Whether or not neoadjuvant chemotherapy was conducted.

        -  Underlying disease.

        -  Adjuvant chemotherapy information.

        -  Other concomitant medication (drugs administered for prevention and treatment of OXLIPN,
           drugs administered for treatment of Grade 3-4 adverse drug reactions/serious adverse
           drug reactions related to the chemotherapy).

        -  Vital signs, height, and weight.

        -  Performance Status evaluation (ECOG PS).

        -  Geriatric Assessment (KG-7): for subjects ≥ 65 years old.

        -  Quality of Life assessment (FACT-C, FACT/GOG-NTX-12).

        -  Laboratory test results.

        -  Tumor Marker (CEA, CA 19-9) test results.

        -  Molecular genetic test results (MSI [microsatellite instability] and/or MMR [DNA
           mismatch repair gene], immunohistochemistry test for protein, KRAS, NRAS, BRAF etc.).

        -  Colonoscopy/CT results.

        -  Disease event (relapse, metastasis or new primary malignant tumor).

        -  Survival of subjects.

        -  Oxaliplatin-induced Peripheral Neuropathy (OXLIPN): Only when oxaliplatin is
           administered.

        -  Grade 3-4 adverse drug reactions related to chemotherapy (based on CTCAE v.5.0).

        -  Serious adverse drug reactions.
observational model: Cohort
time perspective: Prospective
measure: Type of adjuvant chemotherapy
time frame: through adjuvant chemotherapies completion, an average of 24 weeks
description: Type of adjuvant chemotherapy that were used.
measure: Frequency of adjuvant chemotherapy
time frame: through adjuvant chemotherapies completion, an average of 12 cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days)
description: Frequency of adjuvant chemotherapy that were used.
measure: Disease Free Survival (DFS)
time frame: From date of resection surgery until the date of first documented progression, assessed up to 36 months
description: Time from the date of resection surgery to the date of first relapse,
measure: Overall Survival (OS)
time frame: From date of resection surgery until the date of death, assessed up to 36 months
description: Time from the date of resection surgery to the date of death.
measure: Characteristics of relapsed and metastasis cancers and new primary malignant tumor list.
time frame: up to 36 months
description: Whether locally relapsed, whether metastasis is present, location of metastasis, etc.
measure: Quality of Life Assessment (FACT-C)
time frame: Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Subjects will be asked to complete questionnaires to evaluate their quality of life
measure: Quality of Life Assessment (FACT/GOG-NTX-12)
time frame: Baseline, Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Subjects will be asked to complete questionnaires to evaluate their quality of life
measure: Adverse drug reactions/serious adverse drug reactions
time frame: From the date of adjuvant chemotherapy started until the end of follow-up(36 month)
description: Overall incidence of grade 3-4 adverse drug reactions/serious adverse drug reactions
measure: Oxaliplatin Induced Peripheral Neuropathy, OXLIPN
time frame: From the date of adjuvant chemotherapy started until the end of follow-up(36 month)
description: Overall incidence of Oxaliplatin Induced Peripheral Neuropathy, OXLIPN
measure: Performance Status (ECOG) evaluation results
time frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Frequency and ratio of ECOG evaluation results will be presented by time point.
measure: Results on weight
time frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Descriptive statistics will be presented for the results of weight by time point.
measure: Results on body temperature
time frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Descriptive statistics will be presented for the results of body temperature by time point.
measure: Results on pulse
time frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Descriptive statistics will be presented for the results of pulse by time point.
measure: Results on blood pressure
time frame: Baseline, Each cycle(FOLFOX: each cycle is 14 days, XELOX or Capacitabine: each cycle is 21 days), Month 3 (13 weeks ± 2 weeks), Month 6 (26 weeks ± 2 weeks), Month 12 (52 weeks ± 4 weeks), Month 24 (104 weeks ± 8 weeks), Month 36 (156 weeks ± 8 weeks)
description: Descriptive statistics will be presented for the results of blood pressure by time point.
arm group label: Patients
description: Patients with high-risk stage II or stage III primary colon cancer who have received curative resection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Myung Sook Hong
role: Study Director
affiliation: Boryung Pharmaceutical Co., Ltd
last name: Myung Sook Hong
phone: 82-2-708-8238
email: mshong@boryung.co.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Colonic Neoplasms