Clinical trial · Interventional
LESs Surgical Radicality for EaRly Stage Cervical Cancer
A Proof of Concept Non-inferiority Trial Evaluating the Safety and Efficacy of Extrafascial Hysterectomy Plus Pelvic Lymph-node Dissection in Patients With Stage IA2-IB1 Cervical Cancer ≤ 2cm
NCT02613286CI-TRIAL-00059089LESSERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extrafascial Hysterectomy | Procedure | — | UNRESOLVED |
| Modified radical hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Extrafascial Hysterectomy
- description
- Type A hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.
- interventionNames
- Procedure: Extrafascial Hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- Modified radical hysterectomy
- description
- Type B2 hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.
- interventionNames
- Procedure: Modified radical hysterectomy
Primary outcomes (1)
- measure
- Disease Free Survival (3-y DFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCarneiro VCG, Batista TP, Andrade MR, Barros AV, Camara LHLD, Ramalho NM, Lucena MA, Fontao DFS, Tancredi R, Silva Junior TC, Bezerra ALR, Baiocchi G. Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer </=2 cm (LESSER). Int J Gynecol Cancer. 2023 Apr 3;33(4):498-503. doi: 10.1136/ijgc-2022-004092. PMID 36696980