Different Surgical Approaches in Patients of 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.

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

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.

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.

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.

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

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

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.