Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Lei Li700 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

700

Conditions

Uterine Cervical Neoplasm Laparotomy Laparoscopy Survival

Interventions

Laparotomic radical hysterectomyPROCEDURE

Laparotomic radical hysterectomy for patients without fertility requirement

Laparotomic radical trachelectomyPROCEDURE

Laparotomic radical hysterectomy for patients with fertility requirement

Laparoscopic radical hysterectomyPROCEDURE

Laparoscopic radical hysterectomy for patients without fertility requirement

Laparoscopic radical trachelectomyPROCEDURE

Laparoscopic radical hysterectomy for patients with fertility requirement

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Five years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Six months

Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts