- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416748
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer (LASH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolò Bizzarri, MD
- Phone Number: 0630155629
- Email: nicolo.bizzarri@yahoo.com
Study Contact Backup
- Name: Matteo Pavone, MD
- Phone Number: 0630155629
- Email: matteopavone.21@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year DFS
Time Frame: 36 months after surgery
|
disease free survival at 3 years
|
36 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3-year recurrence rate (including pelvic recurrence rate)
Time Frame: 36 months after surgery
|
36 months after surgery
|
3-year overall survival
Time Frame: 36 months after surgery
|
36 months after surgery
|
intra-operative and post-operative complications
Time Frame: 36 months after surgery
|
36 months after surgery
|
Rate of upstage after surgery
Time Frame: 36 months after surgery
|
36 months after surgery
|
Collaborators and Investigators
Investigators
- Study Director: Nicolò Bizzarri, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Study Chair: Giovanni Scambia, Prof., Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
- Study Chair: 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
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- LAcc & SHape - LASH trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Minimally invasive simple hysterectomy
-
University Hospitals Cleveland Medical CenterUniversity of Pittsburgh; The Cleveland Clinic; Duke University; Case Western Reserve... and other collaboratorsRecruitingUterine ProlapseUnited States
-
Fondazione Poliambulanza Istituto OspedalieroAssistance Publique - Hôpitaux de Paris; King's College Hospital NHS Trust; Fondazione... and other collaboratorsRecruitingNeoplasm Metastasis | Colorectal Neoplasms MalignantItaly, Belgium, France, Germany, Luxembourg, Netherlands, Norway, Russian Federation, Spain, United Kingdom
-
Canadian Cancer Trials GroupCanadian Institutes of Health Research (CIHR); Institute of Cancer Research... and other collaboratorsActive, not recruitingCervical CancerCanada, France, Austria, Germany, Belgium, United Kingdom, Netherlands, China, Ireland, Norway, Russian Federation
-
Radboud University Medical CenterDutch Heart Foundation; Penumbra Inc.CompletedIntracerebral Hemorrhage | Surgical Procedures, Minimally InvasiveNetherlands
-
Postgraduate Institute of Dental Sciences RohtakCompleted
-
Osama Mohammad Ali ElDamshetyUnknown
-
University of FloridaCompletedStroke | Atrial FibrillationUnited States
-
Istituto Clinico HumanitasFondazione Umberto VeronesiRecruiting
-
Kantonsspital AarauCompletedPostoperative Complications | Intraoperative Complications | Laparoscopic Technique no Switch to Open | Duration of SurgerySwitzerland
-
University of OuluRecruitingEndometriosis | Surgery | Deep EndometriosisFinland