Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Not Applicable

Recruiting

• Conditions: Cervix Cancer; Cervical Cancer

• Registration Number: NCT06416748
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

The Laparoscopic Approach to Cervical Cancer (LACC) Trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. Since then, the standard of care in terms of surgical approach to radical hysterectomy has been considered the laparotomy. More recently, the SHAPE trial results were presented showing that in patients with low-risk cervical cancer (defined as FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on MRI) simple hysterectomy was not inferior to radical hysterectomy for what concerned pelvic recurrence, with less complications and better quality of life. However, SHAPE trial was not designed to assess the surgical approach.

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.

Study Timeline

• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-11
• Study First Posted: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Study Start: 2024-10-27
• Last Update Posted: 2024-10-29
• Primary Completion: 2027-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 974

Inclusion Criteria

• Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma of uterine cervix
• FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤10mm on conization specimen
• FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤50% at pre-conization MRI-scan or "expert" US-scan.
• Age ≥18 years

Exclusion Criteria

• Neuroendocrine, clear cell, serous carcinoma
• Depth of infiltration >10 mm on conization specimen
• Depth of infiltration >50% at pre-conization imaging
• Cervical tumor >2 cm
• Diagnosis on inadvertent hysterectomy
• Neoadjuvant chemotherapy
• Previous pelvic radiotherapy
• Pregnant women
• Contraindications to surgery
• Lymph nodes >15 mm short axis
• Fertility sparing treatment or desire
• Recurrent cervical cancer
• Time between cervical cancer diagnosis and hysterectomy >4 months if conization with tumor negative margins
• Time between cervical cancer diagnosis and hysterectomy >3 months if conization with invasive tumor positive margins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3-year DFS	36 months after surgery	disease free survival at 3 years

Secondary Outcome Measures

Name	Time	Method
intra-operative and post-operative complications	36 months after surgery
Rate of upstage after surgery	36 months after surgery
3-year recurrence rate (including pelvic recurrence rate)	36 months after surgery
3-year overall survival	36 months after surgery

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy