<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/NCT02207660</url>
  </required_header>
  <id_info>
    <org_study_id>201211032RIC</org_study_id>
    <nct_id>NCT02207660</nct_id>
  </id_info>
  <brief_title>Cisplatin Plus One-Day 24-hour Infusion of High-Dose 5-Fluorouracil for Stage IVB, Recurrent or Metastatic Carcinoma of the Uterine Cervix</brief_title>
  <official_title>Cisplatin Plus One Day 24 Hour Infusion of High-Dose 5-Fluorouracil for Stage IVB, Recurrent or Metastatic Carcinoma of the Uterine Cervix.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To evaluate the effectiveness and toxicity of the combination of infusional&#xD;
      cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly&#xD;
      every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.&#xD;
&#xD;
      Methods: The medical records of all patients with stage IVB, recurrent or metastatic cervical&#xD;
      cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at&#xD;
      National Taiwan University Hospital were reviewed.&#xD;
&#xD;
      Expected results: Investigators will identify the effectiveness and toxicity of the&#xD;
      combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus&#xD;
      leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or&#xD;
      metastatic carcinoma of cervix.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The medical records for all patients with advanced, metastatic or recurrent cervical cancer&#xD;
      who were treated with P-HDFL regimen between January 2005 and December 2009 at National&#xD;
      Taiwan University Hospital were reviewed. Recurrences were confirmed by histopathologic&#xD;
      examinations. Cases of recurrent cervical cancer, who undergoing salvage surgery and&#xD;
      receiving P-HDFL as adjuvant therapy, were excluded from this study. The general principles&#xD;
      for patients schedule for P-HDFL regimen treatment were as followings: patients must have had&#xD;
      white cell count &gt; 3000/mm3, platelet count &gt; 100000/mm3, a normal serum creatinine (≦1.5&#xD;
      mg/dL) or a measured creatinine clearance ([urine creatinine level (mg/dL) X 24-hr urine&#xD;
      amount (mL)]/[serum creatinine level (mg/dL) X 1,440 min]) of ≧ 40 mL/min [12,15], total&#xD;
      bilirubin ≦ 2 mg/dL, and transaminase (≦3X the upper normal limits). Also, patients needed to&#xD;
      have measurable disease by radiographic studies (plain X-ray, CT or MRI scans), no serious&#xD;
      active underlying medical issues, and Eastern Cooperative Oncology Group (ECOG) performance&#xD;
      status of 0 to 2. The ethical approval for this retrospective study was obtained from our&#xD;
      research ethics committee in this hospital.&#xD;
&#xD;
      The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour&#xD;
      infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2&#xD;
      intravenous 24-hour infusion on Day 1. Normal saline hydration (≧1000 mL), dexamethasone, and&#xD;
      antiemetics (ondansetron or granisetron) were given prophylactically before each dose of&#xD;
      cisplatin.&#xD;
&#xD;
      Physical examination, survey of adverse reactions and hemogram checkup of patients were&#xD;
      performed before administering each dose of the P-HDFL treatment. Tumor response and toxicity&#xD;
      were evaluated according to the World Health Organization criteria [16]. A complete response&#xD;
      (CR) was defined as the disappearance of all measurable disease for at least 4 weeks. A&#xD;
      partial response (PR) was defined as a 50% or more reduction in the products of each&#xD;
      measurable lesion for at least 4 weeks. Progressive disease (PD) was defined as a 25% or more&#xD;
      increase in the size of one or more measurable lesions or the appearance of new lesions.&#xD;
      Stable disease (SD) was defined as any condition not meeting any the above criteria.&#xD;
&#xD;
      Progression-free survival was measured from the first date of chemotherapy to the date of&#xD;
      documented disease progression, death of other causes or last contact. Overall survival was&#xD;
      measured from the first date of chemotherapy to death or last contact. Progression-free&#xD;
      survival and overall survival were estimated by using the method of Kaplan-Meier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>From the first date of chemotherapy to death or last contact.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>From the first date of chemotherapy to the date of documented disease progression, death of other causes or last contact.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Cisplatin,P-HDFL</arm_group_label>
    <description>The general principles for patients schedule for P-HDFL regimen treatment were as followings: patients must have had white cell count &gt; 3000/mm3, platelet count &gt; 100000/mm3, a normal serum creatinine (≦1.5 mg/dL) or a measured creatinine clearance ([urine creatinine level (mg/dL) X 24-hr urine amount (mL)]/[serum creatinine level (mg/dL) X 1,440 min]) of ≧ 40 mL/min [12,15], total bilirubin ≦ 2 mg/dL, and transaminase (≦3X the upper normal limits). Also, patients needed to have measurable disease by radiographic studies (plain X-ray, CT or MRI scans), no serious active underlying medical issues, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin,P-HDFL</intervention_name>
    <description>The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2 intravenous 24-hour infusion on Day 1. Normal saline hydration (≧1000 mL), dexamethasone, and antiemetics (ondansetron or granisetron) were given prophylactically before each dose of cisplatin.</description>
    <arm_group_label>Cisplatin,P-HDFL</arm_group_label>
    <other_name>Abilatin、Platamine、Platinex</other_name>
    <other_name>fluorouracil</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The general principles for patients schedule for P-HDFL regimen treatment were as&#xD;
        followings: patients must have had white cell count &gt; 3000/mm3, platelet count &gt;&#xD;
        100000/mm3, a normal serum creatinine (≦1.5 mg/dL) or a measured creatinine clearance&#xD;
        ([urine creatinine level (mg/dL) X 24-hr urine amount (mL)]/[sereum creatinine level&#xD;
        (mg/dL) X 1,440 min]) of ≧ 40 mL/min [12,15], total bilirubin ≦ 2 mg/dL, and transaminase&#xD;
        (≦3X the upper normal limits). Also, patients needed to have measurable disease by&#xD;
        radiographic studies (plain X-ray, CT or MRI scans), no serious active underlying medical&#xD;
        issues, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with stage IVB, recurrent or metastatic cervical cancer who were treated&#xD;
             with P-HDFL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cases of recurrent cervical cancer, who undergoing salvage surgery and receiving&#xD;
             P-HDFL as adjuvant therapy, were excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi-An Chen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 3, 2013</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cisplatin</keyword>
  <keyword>Cervical cancer</keyword>
  <keyword>metastasis</keyword>
  <keyword>recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorouracil</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/NCT02207660
org study id: 201211032RIC
nct id: NCT02207660
lead sponsor: 
has dmc: Yes
Objectives: To evaluate the effectiveness and toxicity of the combination of infusional
      cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly
      every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.

      Methods: The medical records of all patients with stage IVB, recurrent or metastatic cervical
      cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at
      National Taiwan University Hospital were reviewed.

      Expected results: Investigators will identify the effectiveness and toxicity of the
      combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus
      leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or
      metastatic carcinoma of cervix.
The medical records for all patients with advanced, metastatic or recurrent cervical cancer
      who were treated with P-HDFL regimen between January 2005 and December 2009 at National
      Taiwan University Hospital were reviewed. Recurrences were confirmed by histopathologic
      examinations. Cases of recurrent cervical cancer, who undergoing salvage surgery and
      receiving P-HDFL as adjuvant therapy, were excluded from this study. The general principles
      for patients schedule for P-HDFL regimen treatment were as followings: patients must have had
      white cell count > 3000/mm3, platelet count > 100000/mm3, a normal serum creatinine (≦1.5
      mg/dL) or a measured creatinine clearance ([urine creatinine level (mg/dL) X 24-hr urine
      amount (mL)]/[serum creatinine level (mg/dL) X 1,440 min]) of ≧ 40 mL/min [12,15], total
      bilirubin ≦ 2 mg/dL, and transaminase (≦3X the upper normal limits). Also, patients needed to
      have measurable disease by radiographic studies (plain X-ray, CT or MRI scans), no serious
      active underlying medical issues, and Eastern Cooperative Oncology Group (ECOG) performance
      status of 0 to 2. The ethical approval for this retrospective study was obtained from our
      research ethics committee in this hospital.

      The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour
      infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2
      intravenous 24-hour infusion on Day 1. Normal saline hydration (≧1000 mL), dexamethasone, and
      antiemetics (ondansetron or granisetron) were given prophylactically before each dose of
      cisplatin.

      Physical examination, survey of adverse reactions and hemogram checkup of patients were
      performed before administering each dose of the P-HDFL treatment. Tumor response and toxicity
      were evaluated according to the World Health Organization criteria [16]. A complete response
      (CR) was defined as the disappearance of all measurable disease for at least 4 weeks. A
      partial response (PR) was defined as a 50% or more reduction in the products of each
      measurable lesion for at least 4 weeks. Progressive disease (PD) was defined as a 25% or more
      increase in the size of one or more measurable lesions or the appearance of new lesions.
      Stable disease (SD) was defined as any condition not meeting any the above criteria.

      Progression-free survival was measured from the first date of chemotherapy to the date of
      documented disease progression, death of other causes or last contact. Overall survival was
      measured from the first date of chemotherapy to death or last contact. Progression-free
      survival and overall survival were estimated by using the method of Kaplan-Meier.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival
time frame: 5 years
description: From the first date of chemotherapy to death or last contact.
measure: Progression-free survival
time frame: 5 years
description: From the first date of chemotherapy to the date of documented disease progression, death of other causes or last contact.
arm group label: Cisplatin,P-HDFL
description: The general principles for patients schedule for P-HDFL regimen treatment were as followings: patients must have had white cell count > 3000/mm3, platelet count > 100000/mm3, a normal serum creatinine (≦1.5 mg/dL) or a measured creatinine clearance ([urine creatinine level (mg/dL) X 24-hr urine amount (mL)]/[serum creatinine level (mg/dL) X 1,440 min]) of ≧ 40 mL/min [12,15], total bilirubin ≦ 2 mg/dL, and transaminase (≦3X the upper normal limits). Also, patients needed to have measurable disease by radiographic studies (plain X-ray, CT or MRI scans), no serious active underlying medical issues, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
intervention type: Drug
intervention name: Cisplatin,P-HDFL
description: The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2 intravenous 24-hour infusion on Day 1. Normal saline hydration (≧1000 mL), dexamethasone, and antiemetics (ondansetron or granisetron) were given prophylactically before each dose of cisplatin.
arm group label: Cisplatin,P-HDFL
other name: Abilatin、Platamine、Platinex
other name: fluorouracil
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Chi-An Chen, MD
role: Study Chair
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Fluorouracil