Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Cervical Cancer Clinical Trial

— LASH  

Official title:

Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416748
• Other study ID #: LAcc & SHape - LASH trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2030

Study information

• Verified date: May 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Nicolò Bizzarri, MD
• Phone: 0630155629
• Email: nicolo.bizzarri[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 575
• Est. completion date: July 1, 2030
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• 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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

References & Publications (2)

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 SH — View 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 Hysterec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year DFS	disease free survival at 3 years	36 months after surgery
Secondary	3-year recurrence rate (including pelvic recurrence rate)		36 months after surgery
Secondary	3-year overall survival		36 months after surgery
Secondary	intra-operative and post-operative complications		36 months after surgery
Secondary	Rate of upstage after surgery		36 months after surgery