search
Back to results

Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Class II hysterectomy
Sponsored by
Chinese Gynecological Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Stage IA2 and small IB1 <2 cm
  2. Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen
  3. Squamous OR adenocarcinoma OR adenosquamous
  4. Grade 1, 2 and 3
  5. Lymph-vascular space invasion (LVSI): presence or absence
  6. Diagnosis confirmed by LEEP/cone/cervical biopsy
  7. Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only
  8. Abdomino-pelvic CT scan in patients with negative LEEP-cone margins
  9. No contraindications to surgery
  10. No desire to preserve fertility
  11. Informed consent

Exclusion Criteria:

  1. High-risk histology types (clear cell, small cell etc)
  2. Evidence of lymph node metastasis on preoperative imaging
  3. Stage 1A1
  4. Neo-adjuvant chemotherapy
  5. Pregnancy
  6. Desire to preserve fertility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Class III hysterectomy Arm

    Class II hysterectomy Arm

    Arm Description

    Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time.

    Class II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time.

    Outcomes

    Primary Outcome Measures

    3-year disease-free survival (DFS) rate

    Secondary Outcome Measures

    Treatment-related toxicity
    Post-operation quality of life
    Cost effective
    Pelvic and/or extra-pelvic relapse rate
    Overall survival
    Node number involved in retroperitoneal node dissection
    Rates of parametrial, margins and pelvic/para-aortic nodes involvement

    Full Information

    First Posted
    January 18, 2015
    Last Updated
    February 15, 2015
    Sponsor
    Chinese Gynecological Oncology Group
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02368574
    Brief Title
    Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
    Official Title
    Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chinese Gynecological Oncology Group

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).
    Detailed Description
    This is a 1:1 multi-center randomized trial with class II hysterectomy plus node dissection as the experimental arm, and class III hysterectomy plus pelvic node dissection as the control arm. Primary endpoints are: (1). 3-year diseases-free survival (DFS) rate; (2) the rates of treatment-related toxicity; (3) post-operation QoL (including sexual function) and (4) treatment costs. Secondary endpoints are：(1) the rates of pelvic and/or extra-pelvic relapse; (2) overall survival(OS) rate; (3) the numbers of retroperitoneal node dissection, and (4) the rates of parametrial, margins and pelvic/para-aortic nodes involvement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Class III hysterectomy Arm
    Arm Type
    No Intervention
    Arm Description
    Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time.
    Arm Title
    Class II hysterectomy Arm
    Arm Type
    Experimental
    Arm Description
    Class II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time.
    Intervention Type
    Procedure
    Intervention Name(s)
    Class II hysterectomy
    Intervention Description
    Class II hysterectomy
    Primary Outcome Measure Information:
    Title
    3-year disease-free survival (DFS) rate
    Time Frame
    up to 4 years
    Secondary Outcome Measure Information:
    Title
    Treatment-related toxicity
    Time Frame
    up to 4 years
    Title
    Post-operation quality of life
    Time Frame
    up to 4 years
    Title
    Cost effective
    Time Frame
    up to 4 years
    Title
    Pelvic and/or extra-pelvic relapse rate
    Time Frame
    up to 4 years
    Title
    Overall survival
    Time Frame
    up to 4 years
    Title
    Node number involved in retroperitoneal node dissection
    Time Frame
    up to 4 years
    Title
    Rates of parametrial, margins and pelvic/para-aortic nodes involvement
    Time Frame
    up to 4 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stage IA2 and small IB1 <2 cm Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen Squamous OR adenocarcinoma OR adenosquamous Grade 1, 2 and 3 Lymph-vascular space invasion (LVSI): presence or absence Diagnosis confirmed by LEEP/cone/cervical biopsy Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only Abdomino-pelvic CT scan in patients with negative LEEP-cone margins No contraindications to surgery No desire to preserve fertility Informed consent Exclusion Criteria: High-risk histology types (clear cell, small cell etc) Evidence of lymph node metastasis on preoperative imaging Stage 1A1 Neo-adjuvant chemotherapy Pregnancy Desire to preserve fertility

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30555800
    Citation
    Sun H, Cao D, Shen K, Yang J, Xiang Y, Feng F, Wu L, Zhang Z, Ling B, Song L. Piver Type II vs. Type III Hysterectomy in the Treatment of Early-Stage Cervical Cancer: Midterm Follow-up Results of a Randomized Controlled Trial. Front Oncol. 2018 Nov 28;8:568. doi: 10.3389/fonc.2018.00568. eCollection 2018.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer

    We'll reach out to this number within 24 hrs