Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03739944
• Other study ID #: RACC
• Status: Recruiting
• Phase: Phase 3
• Start date: November 23, 2018
• Est. completion date: November 23, 2023

Study information

• Verified date: December 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: 13911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 23, 2023
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cost-Benefit Analysis
• Laparoscopy
• Laparotomy
• Morbidity
• Mortality
• Pelvic Floor Disorders
• Quality of Life
• Survival
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Laparotomic radical hysterectomy
Laparotomic radical hysterectomy for patients without fertility requirement
• Laparotomic radical trachelectomy
Laparotomic radical hysterectomy for patients with fertility requirement
• Laparoscopic radical hysterectomy
Laparoscopic radical hysterectomy for patients without fertility requirement
• Laparoscopic radical trachelectomy
Laparoscopic radical hysterectomy for patients with fertility requirement

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

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