Minimally invasive simple hysterectomy in low-risk cervical cancer: a single-arm trial with stopping rules (ENGOT-cx23/MITO/LASH trial)

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F25%3A10498518" target="_blank" >RIV/00064165:_____/25:10498518 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/25:10498518

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=9B2O84EkD3" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=9B2O84EkD3</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ijgc.2025.101818" target="_blank" >10.1016/j.ijgc.2025.101818</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Minimally invasive simple hysterectomy in low-risk cervical cancer: a single-arm trial with stopping rules (ENGOT-cx23/MITO/LASH trial)

Popis výsledku v původním jazyce

Background: The oncologic safety of minimally invasive simple hysterectomy in low-risk cervical cancer has not been explored by an adequately powered clinical trial. Primary Objective: This study aims to evaluate whether minimally invasive simple hysterectomy affects disease-free survival in low-risk early-stage cervical cancer. Study Hypothesis: Minimally invasive simple hysterectomy represents an oncologically safe approach in selected patients with low-risk cervical cancer. Trial Design: This is a single-arm trial with stopping rules. All patients must undergo cervical conization. Patients with clear conization margins or absence of residual macroscopic disease at imaging after conization (re-conization is mandatory if these criteria are not met) are submitted to minimally invasive (laparoscopy or robot-assisted laparoscopy) simple hysterectomy with sentinel lymph node biopsy algorithm. Adjuvant therapy is given in case of tumor-involved surgical margins, and/or metastatic lymph nodes, and/or substantial lymphovascular space invasion with depth of stromal infiltration &gt;2/3 (or tumor-free distance &lt;3 mm). Major Inclusion/Exclusion Criteria: The major inclusion criteria are: squamous cell carcinoma, human papillomavirus-related adenocarcinoma, adenosquamous carcinoma of the uterine cervix; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (&lt;2 cm) with depth of infiltration &lt;10 mm on conization specimen; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (&lt;2 cm) with depth of infiltration &lt;50% at pre-conization magnetic resonance imaging scan or &quot;expert&quot; ultrasound scan. Women are not eligible if they have evidence of metastatic disease, contraindications to surgery and/or lymph node assessment, or fertility sparing desire. Primary Endpoint: The primary end point is 3-year disease-free survival of patients who undergo minimally invasive simple hysterectomy. Sample Size: A sample size of 974 patients will give a power of 80% at a significance level of 2.5% (1-sided) to reject the null hypothesis of a 3-year recurrence rate of 2.4%, assuming a 3-year recurrence rate of 1.2%. A maximum of 14 recurrences at 3 years should be observed to reject the null hypothesis. A stopping rule based on the number of recurrences observed at different timepoints will be implemented to avoid a higher recurrence rate with the study procedure. The trial will also be stopped if no recurrences are observed in the first 400 patients followed up for 2 years. Estimated Dates for Completing Accrual and Presenting Results: The enrolment will last 60 months. After the surgery, the follow-up time will be &gt;= 3 years.

Název v anglickém jazyce

Minimally invasive simple hysterectomy in low-risk cervical cancer: a single-arm trial with stopping rules (ENGOT-cx23/MITO/LASH trial)

Popis výsledku anglicky

Background: The oncologic safety of minimally invasive simple hysterectomy in low-risk cervical cancer has not been explored by an adequately powered clinical trial. Primary Objective: This study aims to evaluate whether minimally invasive simple hysterectomy affects disease-free survival in low-risk early-stage cervical cancer. Study Hypothesis: Minimally invasive simple hysterectomy represents an oncologically safe approach in selected patients with low-risk cervical cancer. Trial Design: This is a single-arm trial with stopping rules. All patients must undergo cervical conization. Patients with clear conization margins or absence of residual macroscopic disease at imaging after conization (re-conization is mandatory if these criteria are not met) are submitted to minimally invasive (laparoscopy or robot-assisted laparoscopy) simple hysterectomy with sentinel lymph node biopsy algorithm. Adjuvant therapy is given in case of tumor-involved surgical margins, and/or metastatic lymph nodes, and/or substantial lymphovascular space invasion with depth of stromal infiltration &gt;2/3 (or tumor-free distance &lt;3 mm). Major Inclusion/Exclusion Criteria: The major inclusion criteria are: squamous cell carcinoma, human papillomavirus-related adenocarcinoma, adenosquamous carcinoma of the uterine cervix; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (&lt;2 cm) with depth of infiltration &lt;10 mm on conization specimen; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (&lt;2 cm) with depth of infiltration &lt;50% at pre-conization magnetic resonance imaging scan or &quot;expert&quot; ultrasound scan. Women are not eligible if they have evidence of metastatic disease, contraindications to surgery and/or lymph node assessment, or fertility sparing desire. Primary Endpoint: The primary end point is 3-year disease-free survival of patients who undergo minimally invasive simple hysterectomy. Sample Size: A sample size of 974 patients will give a power of 80% at a significance level of 2.5% (1-sided) to reject the null hypothesis of a 3-year recurrence rate of 2.4%, assuming a 3-year recurrence rate of 1.2%. A maximum of 14 recurrences at 3 years should be observed to reject the null hypothesis. A stopping rule based on the number of recurrences observed at different timepoints will be implemented to avoid a higher recurrence rate with the study procedure. The trial will also be stopped if no recurrences are observed in the first 400 patients followed up for 2 years. Estimated Dates for Completing Accrual and Presenting Results: The enrolment will last 60 months. After the surgery, the follow-up time will be &gt;= 3 years.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

International Journal of Gynecological Cancer

ISSN

1048-891X

e-ISSN

1525-1438

Svazek periodika

35

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

101818

Kód UT WoS článku

001487682800001

EID výsledku v databázi Scopus

2-s2.0-105004076808