Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Laparotomic radical hysterectomy
* Procedure: Laparotomic radical trachelectomy
* Procedure: Laparoscopic radical hysterectomy
* Procedure: Laparoscopic radical trachelectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparotomic radical hysterectomy<br> | Procedure: Laparotomic radical hysterectomy<br>* Laparotomic radical hysterectomy for patients without fertility requirement<br>|
| Active Comparator: Laparotomic radical trachelectomy<br> | Procedure: Laparotomic radical trachelectomy<br>* Laparotomic radical hysterectomy for patients with fertility requirement<br>|
| Active Comparator: Laparoscopic radical hysterectomy<br> | Procedure: Laparoscopic radical hysterectomy<br>* Laparoscopic radical hysterectomy for patients without fertility requirement<br>|
| Active Comparator: Laparoscopic radical trachelectomy<br> | Procedure: Laparoscopic radical trachelectomy<br>* Laparoscopic radical hysterectomy for patients with fertility requirement<br>|

What is the study measuring?
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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 |