About this trial
Radical hysterectomy and pelvic lymph node dissection (+/- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. And minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. This study aims to compare total laparoscopic radical hysterectomy and total abdominal radical hysterectomy in terms of disease-free survival and overall survival. Rates and characteristics of recurrence, incidence of complications and morbidity, impact on quality of life and cost-effectiveness will also be determined.
Eligibility criteria
Qualifiers
Patients with histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
Patients with histologically confirmed stage IAI (+) LVSI, IA2, IB1, IB2 and IIA1 disease (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
Patients undergoing a Type II/Type III radical hysterectomy (Piver-Rutledge Classification) or Type B/Type C radical hysterectomy (Querleu-Morrow Classification)
Patients with adequate bone marrow, renal and hepatic function using Standard International Units 4.1 WBC > 3.0 x 109 cells/L 4.2 Platelets > 100 x 109 cells/L 4.3 Creatinine < 2.0 mg/dL 4.4 Bilirubin < 1.5 x upper normal limit and AST/SGOT or ALT/SGPT < 3 x upper normal limit
Disqualifiers
Patients with any histology other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
Stage IB3, IIA2-IV (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
Patients with evidence of metastatic disease by conventional imaging studies (CT Scan, MRI or PET CT Scan), enlarged pelvic or aortic lymph nodes > 2cm, or histologically positive lymph nodes
Patients with a history of pelvic or abdominal radiotherapy
Trial design
Treatments tested in this trial
- radical hysterectomy