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

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Procedure: Class II hysterectomy

• Registration Number: NCT02368574
• Lead Sponsor: Chinese Gynecological Oncology Group

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 Timeline

• Study First Submitted: 2015-01-18
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-15
• Last Update Submitted: 2015-02-15
• Study First Posted: 2015-02-23
• Last Update Posted: 2015-02-23
• Study Start: 2015-03
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Class II hysterectomy Arm	Class II hysterectomy	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.

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival (DFS) rate	up to 4 years

Secondary Outcome Measures

Name	Time	Method
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