Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

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

Interventions

PROCEDURE

Minimally invasive simple hysterectomy

Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 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 over 2/3.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Principal Investigators

• Nicolò Bizzarri, MD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Giovanni Scambia, Prof. · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Denis Querleu, Prof. · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Francesco Fanfani, Prof. · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Anna Fagotti, Prof. · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Gabriella Ferrandina, Prof. · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Valerio Gallotta, MD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

• Luigi Pedone Anchora, MD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-27

Primary Completion

2027-07-01

Completion

2030-07-01

Countries

• Italy

Study Locations