LESs Surgical Radicality for EaRly Stage Cervical Cancer

Summary

This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Outcome Measures

Linked Diseases