## Protocol Section
### Identification Module
**NCT ID:** NCT06416748

**Acronym:** LASH

**Brief Title:** Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

**Official Title:** Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

#### Organization Study ID Info
**ID:** LAcc & SHape - LASH trial
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Status Module
#### Completion Date
**Date:** 2030-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS

#### Responsible Party

**Investigator Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS

**Investigator Full Name:** Bizzarri Nicolò

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 575

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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 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:** Minimally invasive simple hysterectomy

**Other Names:**

- simple hysterectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** disease free survival at 3 years

**Measure:** 3-year DFS

**Time Frame:** 36 months after surgery

#### Secondary Outcomes

**Measure:** 3-year recurrence rate (including pelvic recurrence rate)

**Time Frame:** 36 months after surgery

**Measure:** 3-year overall survival

**Time Frame:** 36 months after surgery

**Measure:** intra-operative and post-operative complications

**Time Frame:** 36 months after surgery

**Measure:** Rate of upstage after surgery

**Time Frame:** 36 months after surgery

### Eligibility Module

**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

**Gender Based:** True

**Gender Description:** female patients meeting the inclusion criteria

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nicolo.bizzarri@yahoo.com

**Name:** Nicolò Bizzarri, MD

**Phone:** 0630155629

**Role:** CONTACT

**Contact 2:**

**Email:** matteopavone.21@gmail.com

**Name:** Matteo Pavone, MD

**Phone:** 0630155629

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Nicolò Bizzarri, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Giovanni Scambia, Prof.

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Denis Querleu, Prof.

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Francesco Fanfani, Prof.

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Anna Fagotti, Prof.

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Gabriella Ferrandina, Prof.

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Valerio Gallotta, MD

**Role:** STUDY_CHAIR

**Official 8:**

**Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

**Name:** Luigi Pedone Anchora, MD

**Role:** STUDY_CHAIR

### References Module

#### 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.

**PMID:** 38416430

**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.

**PMID:** 30380365

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002583

- Term: Uterine Cervical Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
