Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Trial Title: Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

NCT ID: NCT06416748

Condition: Cervical Cancer
Cervix Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
Cervical cancer
Minimally invasive surgery in cervical cancer
Robotic surgery in cervical cancer
Laparoscopic surgery in cervical cancer
LACC trial
SHAPE trial
Low risk cervical cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Intervention model description: 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 >2/3.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Minimally invasive simple hysterectomy
Description: Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: &amp;lt; 10 mm on LEEP/cone and &amp;lt; 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.
Arm group label: single arm

Other name: simple hysterectomy

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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Gender based: Yes

Gender description: female patients meeting the inclusion criteria

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fondazione Policlinico Universitario A. Gemelli IRCCS

Address:
City: Roma
Country: Italy

Status: Recruiting

Contact:
Last name: Matteo Pavone, MD

Phone: 00390630151

Start date: October 27, 2024

Completion date: July 1, 2030

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06416748