Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer (LASH)

October 26, 2024 updated by: Bizzarri Nicolò, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

974

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contact:
          • Matteo Pavone, MD
          • Phone Number: 00390630151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm
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 over 2/3.
Procedure: Minimally invasive simple hysterectomy
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 over 2/3.
Other Names:
  • simple hysterectomy

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

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

May 11, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAcc & SHape - LASH trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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