<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/NCT03295526</url>
  </required_header>
  <id_info>
    <org_study_id>STCSM2016-6-17-1.1</org_study_id>
    <nct_id>NCT03295526</nct_id>
  </id_info>
  <brief_title>Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer</brief_title>
  <official_title>Study on Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      Test name:&#xD;
&#xD;
      Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua&#xD;
      Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3&#xD;
      years Test objectives： The primary goal：The overall therapeutic effect of patients with&#xD;
      selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy.&#xD;
&#xD;
      Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of&#xD;
      postoperative lower limb lymphedema.&#xD;
&#xD;
      The study was designed for prospective, randomized, controlled clinical trials. The number of&#xD;
      subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The&#xD;
      control group was treated with systematic pelvic lymph node dissection group.&#xD;
&#xD;
      Follow-up time: 3 years Sample size: 200 cases&#xD;
&#xD;
      End of the trial:&#xD;
&#xD;
      Primary end-poin:t three-year survival (overall survival, progression-free survival)&#xD;
      Secondary end point: lower limb lymph node lymphedema&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall objective For cervical cancer patients with confirmed lymph node metastasis by&#xD;
      intraoperative frozen pathology, the overall treatment effect of radical hysterectomy and&#xD;
      selective enlarged lymph node dissection is not inferior to systematic pelvic lymphadenectomy&#xD;
      and can reduce postoperative lower limb lymphedema incidence and severity.&#xD;
&#xD;
      1. The purpose of this study&#xD;
&#xD;
        1. to assess whether the progression free survival of patients with selective enlarged&#xD;
           pelvic lymph node resection is better than patients with systematic pelvic lymph node&#xD;
           dissection.&#xD;
&#xD;
        2. to evaluate differences of the incidence and severity of lymphedema between the two&#xD;
           group patients using Lymphedema Staging standards (Stage 0-3) according to the&quot;consensus&#xD;
           document&quot;of the International Society of Lymphology.&#xD;
&#xD;
      2. Preoperative evaluation LEEP, conization or biopsy Vagino-recto-abdominal examination +&#xD;
      Vaginal / vaginal colposcopy examination History of Medical, surgical and childbearing&#xD;
      Complications Physical condition Height and weight History of smoking Pregnancy test Chest&#xD;
      X-ray or chest CT or general PET/CT Abdominal CT or general PET/CT Pelvic MRI/CT or general&#xD;
      PET/CT&#xD;
&#xD;
      3.Protocol Patients with stage IB-IIa cervical cancer were randomly divided into two&#xD;
      groups(Control group and Experimental group).Frozen pathological examination will be&#xD;
      performed during the operation, and patients with positive lymph node metastasis will undergo&#xD;
      radical hysterectomy and systematic pelvic lymphadenectomy or radical hysterectomy and&#xD;
      selective enlarged lymph node dissection according to the patient's group.&#xD;
&#xD;
      4. Postoperative adjuvant therapy All patients with pelvic lymph node metastasis are required&#xD;
      to receive DDP based concurrent chemoradiotherapy.&#xD;
&#xD;
      5.Efficacy evaluation Overall survival (OS): The period from randomization to death for any&#xD;
      cause (for patients who have been loss to follow-up prior to death, the last follow-up time&#xD;
      is calculated as the time of death).&#xD;
&#xD;
      Progression free survival (PFS): The duration from randomization to the earliest date of the&#xD;
      date of tumor progression or the date of death for any cause. If the above standards are not&#xD;
      met, the final evaluation date should be used for analysis.&#xD;
&#xD;
      Assessment of lymphedema in lower extremities: Lymphedema Staging standards (Stage 0-3)&#xD;
      according to the&quot;consensus document&quot;of the International Society of Lymphology were used :&#xD;
&#xD;
      Stage 0 Subclinical with possible clinical evolution Stage I Edema regressing with treatments&#xD;
      with positive pitting test Stage II Edema partially regressing with treatments with negative&#xD;
      pitting test Stage III Elephantiasis with cutaneous complications and recurrent infections.&#xD;
&#xD;
      6. Follow up The patients were followed up every 3 months for the first year, every 4 months&#xD;
      for the second year and every 6 months from the third year.&#xD;
&#xD;
      In addition to routine oncologic follow-up, the stage of patients̛ lower extremity lymphedema&#xD;
      should also be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>Overall survival (OS)</measure>
    <time_frame>3 year</time_frame>
    <description>The period(months) from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free-Survival (PFS)</measure>
    <time_frame>3 year</time_frame>
    <description>The period(months) from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremities lymphedema</measure>
    <time_frame>3 year</time_frame>
    <description>Lymphedema Staging standards (Stage 0-3) according to the&quot;consensus document&quot;of the International Society of Lymphology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lymph nodes debulking surgery.</intervention_name>
    <description>Radical hysterectomy and selective enlarged lymph node dissection</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or&#xD;
             adenosquamous carcinoma.&#xD;
&#xD;
          2. histological grading of cervical cancer is 1, 2, 3 or not.&#xD;
&#xD;
          3. patients in the group must have no reproductive function requirements.&#xD;
&#xD;
          4. Patients must be ≥ 18 years of age.&#xD;
&#xD;
          5. preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement.&#xD;
             Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing.&#xD;
&#xD;
          6. Signed informed consent.&#xD;
&#xD;
          7. Surgery should be completed within 4 weeks after the first diagnosis.&#xD;
&#xD;
          8. patients can receive treatment and follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis.&#xD;
&#xD;
          2. other history of the tumor, but does not include: received appropriate treatment of&#xD;
             non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non&#xD;
             Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence.&#xD;
&#xD;
          3. Those who have received or will receive neoadjuvant chemotherapy.&#xD;
&#xD;
          4. patients with preoperative limb lymphedema or lower extremity venous and lymphatic&#xD;
             reflux disorders.&#xD;
&#xD;
          5. pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaohua WU, PhD &amp; MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan university shanghai cancer center, Deparment of gynecologic oncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shanhui Liang, Dr</last_name>
    <phone>008618616890863</phone>
    <email>dr_lianshanhui@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan university</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang shanhui, Dr</last_name>
      <phone>008618616890863</phone>
      <email>dr_liangshanhui@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xiaohua Wu MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cervical Cancer, Lymph nodes debulking surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295526
org study id: STCSM2016-6-17-1.1
nct id: NCT03295526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Test name:

      Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua
      Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3
      years Test objectives： The primary goal：The overall therapeutic effect of patients with
      selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy.

      Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of
      postoperative lower limb lymphedema.

      The study was designed for prospective, randomized, controlled clinical trials. The number of
      subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The
      control group was treated with systematic pelvic lymph node dissection group.

      Follow-up time: 3 years Sample size: 200 cases

      End of the trial:

      Primary end-poin:t three-year survival (overall survival, progression-free survival)
      Secondary end point: lower limb lymph node lymphedema
Overall objective For cervical cancer patients with confirmed lymph node metastasis by
      intraoperative frozen pathology, the overall treatment effect of radical hysterectomy and
      selective enlarged lymph node dissection is not inferior to systematic pelvic lymphadenectomy
      and can reduce postoperative lower limb lymphedema incidence and severity.

      1. The purpose of this study

        1. to assess whether the progression free survival of patients with selective enlarged
           pelvic lymph node resection is better than patients with systematic pelvic lymph node
           dissection.

        2. to evaluate differences of the incidence and severity of lymphedema between the two
           group patients using Lymphedema Staging standards (Stage 0-3) according to the"consensus
           document"of the International Society of Lymphology.

      2. Preoperative evaluation LEEP, conization or biopsy Vagino-recto-abdominal examination +
      Vaginal / vaginal colposcopy examination History of Medical, surgical and childbearing
      Complications Physical condition Height and weight History of smoking Pregnancy test Chest
      X-ray or chest CT or general PET/CT Abdominal CT or general PET/CT Pelvic MRI/CT or general
      PET/CT

      3.Protocol Patients with stage IB-IIa cervical cancer were randomly divided into two
      groups(Control group and Experimental group).Frozen pathological examination will be
      performed during the operation, and patients with positive lymph node metastasis will undergo
      radical hysterectomy and systematic pelvic lymphadenectomy or radical hysterectomy and
      selective enlarged lymph node dissection according to the patient's group.

      4. Postoperative adjuvant therapy All patients with pelvic lymph node metastasis are required
      to receive DDP based concurrent chemoradiotherapy.

      5.Efficacy evaluation Overall survival (OS): The period from randomization to death for any
      cause (for patients who have been loss to follow-up prior to death, the last follow-up time
      is calculated as the time of death).

      Progression free survival (PFS): The duration from randomization to the earliest date of the
      date of tumor progression or the date of death for any cause. If the above standards are not
      met, the final evaluation date should be used for analysis.

      Assessment of lymphedema in lower extremities: Lymphedema Staging standards (Stage 0-3)
      according to the"consensus document"of the International Society of Lymphology were used :

      Stage 0 Subclinical with possible clinical evolution Stage I Edema regressing with treatments
      with positive pitting test Stage II Edema partially regressing with treatments with negative
      pitting test Stage III Elephantiasis with cutaneous complications and recurrent infections.

      6. Follow up The patients were followed up every 3 months for the first year, every 4 months
      for the second year and every 6 months from the third year.

      In addition to routine oncologic follow-up, the stage of patients̛ lower extremity lymphedema
      should also be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: 3 year
description: The period(months) from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
measure: Progression-Free-Survival (PFS)
time frame: 3 year
description: The period(months) from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.
measure: Lower extremities lymphedema
time frame: 3 year
description: Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.
arm group label: Control group
arm group type: No Intervention
description: IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy
arm group label: Experimental group
arm group type: Experimental
description: IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection.
intervention type: Procedure
intervention name: Lymph nodes debulking surgery.
description: Radical hysterectomy and selective enlarged lymph node dissection
arm group label: Experimental group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaohua WU, PhD & MD
role: Principal Investigator
affiliation: Fudan university shanghai cancer center, Deparment of gynecologic oncology
last name: Shanhui Liang, Dr
phone: 008618616890863
email: dr_lianshanhui@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Xiaohua Wu MD
investigator title: Professor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No