NCT06416748

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
974

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Oct 2024Jul 2030

First Submitted

Initial submission to the registry

May 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

October 27, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

May 11, 2024

Last Update Submit

October 26, 2024

Conditions

Cervical CancerCervix Cancer

Keywords

Cervical cancerMinimally invasive surgery in cervical cancerRobotic surgery in cervical cancerLaparoscopic surgery in cervical cancerLACC trialSHAPE trialLow risk cervical cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year DFS

    disease free survival at 3 years

    36 months after surgery

Secondary Outcomes (4)

  • 3-year recurrence rate (including pelvic recurrence rate)

    36 months after surgery

  • 3-year overall survival

    36 months after surgery

  • intra-operative and post-operative complications

    36 months after surgery

  • Rate of upstage after surgery

    36 months after surgery

Study Arms (1)

single arm

OTHER

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

Interventions

Minimally invasive simple hysterectomyPROCEDURE

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.

Also known as: simple hysterectomy
single arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients meeting the inclusion criteria
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

RECRUITING

Related Publications (3)

  • 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: 38416430RESULT

  • 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: 30380365RESULT

  • Bizzarri 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.

    PMID: 40328196DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nicolò Bizzarri, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Central Study Contacts

Nicolò Bizzarri, MD

CONTACT

0630155629nicolo.bizzarri@yahoo.com

Matteo Pavone, MD

CONTACT

0630155629matteopavone.21@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 11, 2024

First Posted

May 16, 2024

Study Start

October 27, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2030

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

IT(1)