Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Primary Endpoint
- 3-year disease-free survival (DFS) rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Neo-adjuvant chemotherapy
- •Desire to preserve fertility
Arms & Interventions
Class III hysterectomy Arm
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 Arm
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: Class II hysterectomy (Procedure)
Outcomes
Primary Outcomes
3-year disease-free survival (DFS) rate
Time Frame: up to 4 years
Secondary Outcomes
- Post-operation quality of life(up to 4 years)
- Node number involved in retroperitoneal node dissection(up to 4 years)
- Pelvic and/or extra-pelvic relapse rate(up to 4 years)
- Overall survival(up to 4 years)
- Rates of parametrial, margins and pelvic/para-aortic nodes involvement(up to 4 years)
- Treatment-related toxicity(up to 4 years)
- Cost effective(up to 4 years)