Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparotomic radical hysterectomy	Procedure: Laparotomic radical hysterectomy; Laparotomic radical hysterectomy for patients without fertility requirement
Active Comparator: Laparotomic radical trachelectomy	Procedure: Laparotomic radical trachelectomy; Laparotomic radical hysterectomy for patients with fertility requirement
Active Comparator: Laparoscopic radical hysterectomy	Procedure: Laparoscopic radical hysterectomy; Laparoscopic radical hysterectomy for patients without fertility requirement
Active Comparator: Laparoscopic radical trachelectomy	Procedure: Laparoscopic radical trachelectomy; Laparoscopic radical hysterectomy for patients with fertility requirement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	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.	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	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.	Five years
Disease-free survival	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.	Five years
Morbidity rate	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	Six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of different surgical routes	The direct cost of different surgical routes	One year
Quality of life	The quality of life measured by academic questionnaire	Three years
Sex function	Sex function measured by academic questionnaire before and after surgeries	Five years
Urodynamics	Urinary functions are measured by dynamic tests before and after surgeries	Five years
Rectal functions	Rectal functions are measured by dynamic tests before and after surgeries	Five years

Collaborators and Investigators

• Sponsor: Lei Li

Publications and helpful links

General Publications

• Chao X, Li L, Wu M, Wu H, Ma S, Tan X, Zhong S, Lang J. Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China. Trials. 2020 Dec 14;21(1):1022. doi: 10.1186/s13063-020-04938-3.
• Ferrandina G, Corrado G, Scambia G. Minimally invasive surgery and quality of life in cervical cancer. Lancet Oncol. 2020 Jun;21(6):746-748. doi: 10.1016/S1470-2045(20)30161-3. No abstract available.
• Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Lang J, Cheng A, Li W. Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China. BMJ Open. 2019 Jul 29;9(7):e029055. doi: 10.1136/bmjopen-2019-029055.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Anticipated): November 23, 2022
• Study Completion (Anticipated): November 23, 2023

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

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; Pregnancy Complications; Uterine Cervical Neoplasms; Pelvic Floor Disorders
• Other Study ID Numbers: RACC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available to all the researches via public websites.
• IPD Sharing Time Frame: The data will be available once the papers were accepted and be available for ever
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No