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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: &amp;lt; 10 mm on LEEP/cone and &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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive simple hysterectomy | Procedure | Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: &amp;lt; 10 mm on LEEP/cone and &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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year DFS | disease free survival at 3 years | 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year recurrence rate (including pelvic recurrence rate) | 36 months after surgery | |
| 3-year overall survival | 36 months after surgery | |
| intra-operative and post-operative complications |
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Inclusion Criteria:
Exclusion Criteria:
female patients meeting the inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolò Bizzarri, MD | Contact | 0630155629 | nicolo.bizzarri@yahoo.com | |
| Matteo Pavone, MD | Contact | 0630155629 | matteopavone.21@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicolò Bizzarri, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Director |
| Giovanni Scambia, Prof. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38416430 | Result | 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. | |
| 30380365 |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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|
|
| 36 months after surgery |
| Rate of upstage after surgery | 36 months after surgery |
| Denis Querleu, Prof. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Francesco Fanfani, Prof. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Anna Fagotti, Prof. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Gabriella Ferrandina, Prof. | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Valerio Gallotta, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Luigi Pedone Anchora, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome | Study Chair |
| Result |
| 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. |
| 40328196 | Derived | 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.ijgc.2025.101818. Epub 2025 Apr 5. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |