Cervical CancerLASHNCT06416748
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
A study testing Minimally invasive simple hysterectomy in people with Cervical Cancer and Cervix Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervix Cancer
- What is being tested?
- Minimally invasive simple hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 974 participants
- Where
- 1 siteItaly
- Study dates
- 27 Oct 2024to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Matteo Pavone, MD, 00390630151
About this study
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.
Read the 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
- Cervical Cancer, Cervix Cancer
- Being tested
- Minimally invasive simple hysterectomy
- 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
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive simple hysterectomyProcedure or surgery
Also called simple hysterectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimally invasive simple hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year DFS
disease free survival at 3 years
Measured: 36 months after surgery
Secondary outcomes (4)
3-year recurrence rate (including pelvic recurrence rate)
Measured: 36 months after surgery
3-year overall survival
Measured: 36 months after surgery
intra-operative and post-operative complications
Measured: 36 months after surgery
Rate of upstage after surgery
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start27 Oct 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- None (open label)
- Enrolment
- 974 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bizzarri Nicolò, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Nicolò Bizzarri, MD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeGiovanni Scambia, Prof., Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeDenis Querleu, Prof., Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeFrancesco Fanfani, Prof., Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeAnna Fagotti, Prof., Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeGabriella Ferrandina, Prof., Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeValerio Gallotta, MD, Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, RomeLuigi Pedone Anchora, MD, Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416748
- Sponsor's protocol ID
- LAcc & SHape - LASH trial
- Acronym
- LASH
- Status last verified
- Oct 2024
- First submitted
- 11 May 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38416430Ramirez 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.
PubMed 30380365Bizzarri 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.
PubMed 40328196
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
- ClinicalTrials.gov ID
- NCT06416748
- Acronym / sponsor ID
- LASH / LAcc & SHape - LASH trial
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 974 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Procedure: Minimally invasive simple hysterectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive simple hysterectomyAlso: simple hysterectomyPatients 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. | Procedure or surgery | single arm |
Primary outcome
3-year DFS
Time frame: 36 months after surgery
disease free survival at 3 years
4 secondary outcomes
3-year recurrence rate (including pelvic recurrence rate)
Time frame: 36 months after surgery
3-year overall survival
Time frame: 36 months after surgery
intra-operative and post-operative complications
Time frame: 36 months after surgery
Rate of upstage after surgery
Time frame: 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: PubMed 38416430Plante 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.
- Results publication: PubMed 30380365Ramirez 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.
- Derived from this study: PubMed 40328196Bizzarri 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.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolò Bizzarri, MD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
Giovanni Scambia, Prof. study chair
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
Denis Querleu, Prof. study chair
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive simple hysterectomy in people with Cervical Cancer and Cervix Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolò Bizzarri, MD (0630155629, nicolo.bizzarri@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS (time frame: 36 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06416748, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.