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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Class II hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Class III hysterectomy Arm<br>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. | |
| Experimental: Class II hysterectomy Arm<br>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. | Procedure: Class II hysterectomy<br>* Class II hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival (DFS) rate |  | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related toxicity |  | up to 4 years | 
| Post-operation quality of life |  | up to 4 years | 
| Cost effective |  | up to 4 years | 
| Pelvic and/or extra-pelvic relapse rate |  | up to 4 years | 
| Overall survival |  | up to 4 years | 
| Node number involved in retroperitoneal node dissection |  | up to 4 years | 
| Rates of parametrial, margins and pelvic/para-aortic nodes involvement |  | up to 4 years |