Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Lei Li

Status and phase: Unknown; Phase 3

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

Treatments: Procedure: Laparotomic radical hysterectomy; Procedure: Laparoscopic radical trachelectomy; Procedure: Laparoscopic radical hysterectomy; Procedure: Laparotomic radical trachelectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03739944

RACC

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 4 patient groups

Laparotomic radical hysterectomy

Active Comparator group

Treatment:

Procedure: Laparotomic radical hysterectomy

Laparotomic radical trachelectomy

Active Comparator group

Treatment:

Procedure: Laparotomic radical trachelectomy

Laparoscopic radical hysterectomy

Active Comparator group

Treatment:

Procedure: Laparoscopic radical hysterectomy

Laparoscopic radical trachelectomy

Active Comparator group

Treatment:

Procedure: Laparoscopic radical trachelectomy