Interventional Recruiting
NCT06416748 on ClinicalTrials.gov
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
- Sponsor: Agostino Gemelli University Polyclinic
- Enrollment: 974 (Estimated)
- Study start: 2024-10-27 (Actual)
- Primary completion: 2027-07-01 (Estimated)
- Study completion: 2030-07-01 (Estimated)
- Allocation: Non-Randomized
- InterventionModel: Single Group
- InterventionModelDescription: Patients with SHAPE inclusion criteria (FIGO 2018 stage IA 2 and IB 1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on imaging) should undergo conization with surgical margins free from invasive disease or conization with involved surgical margins followed by MRI scan or expert ultrasound scan showing no residual disease. In case of residual disease at post conization imaging still fitting inclusion criteria, another conization is recommended. After these steps minimally invasive (laparoscopy or robotic) simple hysterectomy is performed with sentinel lymph node biopsy algorithm. Adjuvant therapy is given only in case of positive surgical margins, metastatic lymph nodes, and extensive LVSI with depth of stromal infiltration \>2/3.
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.
Conditions
- Cervical Cancer
- Cervix Cancer
Intervention / Treatment
- Procedure: Minimally invasive simple hysterectomy
Primary Outcome Measures
-
3-year DFS
(36 months after surgery)
disease free survival at 3 years
Countries
Italy
Locations and Investigators
-
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy (Recruiting)
- Matteo Pavone, MD
Study Officials
- Nicolò Bizzarri, MD (Study Director) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Giovanni Scambia, Prof. (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Denis Querleu, Prof. (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Francesco Fanfani, Prof. (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Anna Fagotti, Prof. (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Gabriella Ferrandina, Prof. (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Valerio Gallotta, MD (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Luigi Pedone Anchora, MD (Study Chair) — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome