LESs Surgical Radicality for EaRly Stage Cervical Cancer

The purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection, in patients with early stage IA2-IB1 cervical cancer ≤ 2cm. The experimental procedure will be considered to be promising for treatment of stage IA2-IB1 cervical cancer ≤ 2cm if the Bayesian posterior probability of "the difference of the 3-y DFS rate is less than the non-inferiority margin of 5%" is at least 50%. Thus, using this proof of concept design, the planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the above criteria, under the hypothesis that the lowest 3-y DFS rate in each arm is 90%. As required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria.

Inclusion criteria

• Patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by LEEP, cone or cervical biopsy;
• Aged between 18 and 70 years;
• performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
• FIGO early stage IA2-IB1 ≤ 2cm;
• Appropriated cardio-respiratory, hepato-renal and hematological reserves; and
• Signing of the Consent Form.

Exclusion criteria

• Limiting systemic comorbidities including neuro-psychiatric disorders or obesity;
• Apparent or confirmed uncontrolled infections;
• Other malignancies in activity;
• Previous radiation or chemotherapy treatment or major pelvic surgery;
• History of drug allergies, and pregnancy or breast feeding; and
• Evidence of more extensive disease at the time of surgery.