Clinical trial NCT03739944: Different Surgical Approaches in Patients of Early-stage Cervical Cancer
Official title: Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uterine Cervical Neoplasm
Laparotomy
Laparoscopy
Survival
Mortality
Morbidity
Quality of Life
Pelvic Floor Disorders
Cost-Benefit Analysis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: Five years
Secondary outcomes:
measure: Overall survival
timeFrame: Five years
measure: Disease-free survival
timeFrame: Five years
measure: Morbidity rate
timeFrame: Six months
Other outcomes:
measure: Cost-effectiveness of different surgical routes
timeFrame: One year
measure: Quality of life
timeFrame: Three years
measure: Sex function
timeFrame: Five years
measure: Urodynamics
timeFrame: Five years
measure: Rectal functions
timeFrame: Five years
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.