Clinical trial NCT06416748: Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Official title: Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Cervix Cancer
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
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 974
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

Brief 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.

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

Primary outcomes:
measure: 3-year DFS
timeFrame: 36 months after surgery
Secondary outcomes:
measure: 3-year recurrence rate (including pelvic recurrence rate)
timeFrame: 36 months after surgery
measure: 3-year overall survival
timeFrame: 36 months after surgery
measure: intra-operative and post-operative complications
timeFrame: 36 months after surgery
measure: Rate of upstage after surgery
timeFrame: 36 months after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Nicolò Bizzarri, MD
role: STUDY_DIRECTOR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Giovanni Scambia, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Denis Querleu, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Francesco Fanfani, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Anna Fagotti, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Gabriella Ferrandina, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Valerio Gallotta, MD
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Luigi Pedone Anchora, MD
role: STUDY_CHAIR
References:
citation: 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: 10.1056/NEJMoa2308900.
citation: 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.