Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Uterine Cervical Neoplasm
- Sponsor
- Lei Li
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Last Updated
- 7 years ago
Overview
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.
Investigators
Lei Li
Professor
Peking Union Medical College Hospital
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
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Five years
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.
Secondary Outcomes
- Morbidity rate(Six months)
- Overall survival(Five years)
- Disease-free survival(Five years)