Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Phase 3

• Conditions: Uterine Cervical Neoplasm; Laparotomy; Mortality; Pelvic Floor Disorders; Cost-Benefit Analysis; Laparoscopy; Morbidity; Quality of Life; Survival
• Interventions: Procedure: Laparotomic radical hysterectomy; Procedure: Laparotomic radical trachelectomy; Procedure: Laparoscopic radical trachelectomy; Procedure: Laparoscopic radical hysterectomy

• Registration Number: NCT03739944
• Lead Sponsor: Lei Li

Brief Summary

This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Start: 2018-11-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-28
• Primary Completion: 2022-11-23
• Study Completion: 2023-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

• Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
• FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
• Type II or III radical hysterectomy or trachelectomy
• Performance status of ECOG 0-1
• Aged 18 years or older
• Signed an approved informed consents

Exclusion Criteria

• Not satisfying any of the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparotomic radical hysterectomy	Laparotomic radical hysterectomy	-
Laparotomic radical trachelectomy	Laparotomic radical trachelectomy	-
Laparoscopic radical trachelectomy	Laparoscopic radical trachelectomy	-
Laparoscopic radical hysterectomy	Laparoscopic radical hysterectomy	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Five years	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Secondary Outcome Measures

Name	Time	Method
Morbidity rate	Six months	Refers to having a disease or a symptom of disease, or to the amount of disease within a population. In this study, morbidity of six months from the surgery is defined according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Overall survival	Five years	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Disease-free survival	Five years	In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China