Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Minimally invasive simple hysterectomy
  Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \&amp;amp;lt; 10 mm on LEEP/cone and \&amp;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 recommend

Первичные конечные точки

• 3-year DFS [Срок оценки: 36 months after surgery]

Вторичные конечные точки (4)

• 3-year recurrence rate (including pelvic recurrence rate) [Срок оценки: 36 months after surgery]
• 3-year overall survival [Срок оценки: 36 months after surgery]
• intra-operative and post-operative complications [Срок оценки: 36 months after surgery]
• Rate of upstage after surgery [Срок оценки: 36 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Публикации

• Plante 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: 10.1 PMID 38416430
• Ramirez 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
• Bizzarri 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.ij PMID 40328196

Идентификаторы

NCT: NCT06416748 · LAcc & SHape - LASH trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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