Different Surgical Approaches in Patients of Early-stage Cervical Cancer

• Sponsor: Lei Li (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03739944
• Collaborator: (none)
• Enrollment: 700
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 11.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasm; Laparotomy; Laparoscopy; Survival; Mortality; Morbidity; Quality of Life; Pelvic Floor Disorders; Cost-Benefit Analysis	Procedure: Laparotomic radical hysterectomy; Procedure: Laparotomic radical trachelectomy; Procedure: Laparoscopic radical hysterectomy; Procedure: Laparoscopic radical trachelectomy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
• Actual Study Start Date: Nov 23, 2018
• Anticipated Primary Completion Date: Nov 23, 2022
• Anticipated Study Completion Date: Nov 23, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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

Other Outcome Measures

1. Cost-effectiveness of different surgical routes [One year]

   The direct cost of different surgical routes

2. Quality of life [Three years]

   The quality of life measured by academic questionnaire

3. Sex function [Five years]

   Sex function measured by academic questionnaire before and after surgeries

4. Urodynamics [Five years]

   Urinary functions are measured by dynamic tests before and after surgeries

5. Rectal functions [Five years]

   Rectal functions are measured by dynamic tests before and after surgeries

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Lei Li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03739944
• Other Study ID Numbers: RACC
• First Posted: Nov 14, 2018
• Last Update Posted: Dec 28, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Pelvic Floor Disorders

Study Results

No Results Posted as of Dec 28, 2018