Clinical trial · Interventional
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
NCT06416748CI-TRIAL-00082044LASHrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervix Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally invasive simple hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single arm
- 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 over 2/3.
- interventionNames
- Procedure: Minimally invasive simple hysterectomy
Primary outcomes (1)
- measure
- 3-year DFS
- timeFrame
- 36 months after surgery
- description
- disease free survival at 3 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTPlante M, Kwon JS, Ferguson S, Samouelian V, Ferron G, Maulard A, de Kroon C, Van Driel W, Tidy J, Williamson K, Mahner S, Kommoss S, Goffin F, Tamussino K, Eyjolfsdottir B, Kim JW, Gleeson N, Brotto L, Tu D, Shepherd LE; CX.5 SHAPE investigators; CX.5 SHAPE Investigators. Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer. N Engl J Med. 2024 Feb 29;390(9):819-829. doi: 10.1056/NEJMoa2308900. PMID 38416430
- RESULTRamirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31. PMID 30380365
- DERIVEDBizzarri N, Querleu D, Ramirez PT, Plante M, Giannarelli D, Falconer H, Abu-Rustum NR, Cibula D, Martinez A, Laas E, Fotopoulou C, Chiva L, Pavone M, Pedone Anchora L, Fanfani F, Fagotti A, Scambia G. Minimally invasive simple hysterectomy in low-risk cervical cancer: a single-arm trial with stopping rules (ENGOT-cx23/MITO/LASH trial). Int J Gynecol Cancer. 2025 Jun;35(6):101818. doi: 10.1016/j.ijgc.2025.101818. Epub 2025 Apr 5. PMID 40328196