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

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).

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: Class II hysterectomy

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Procedure: Class II hysterectomy; Class II hysterectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	up to 4 years
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
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

Collaborators and Investigators

• Sponsor: Chinese Gynecological Oncology Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 18, 2015
• First Submitted That Met QC Criteria: February 15, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 15, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CGOG-001