Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
974 participants
Oct 27, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria14
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06416748