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NCT Number: NCT06416748

Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

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.

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Key information

Conditions

Cervical Cancer Cervix Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Location status: Recruiting

Location contact

Matteo Pavone, MD

CONTACT

00390630151

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive simple hysterectomy

Procedure

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.

Other names: simple hysterectomy

Primary outcomes

  1. 3-year DFS

    Time frame: 36 months after surgery

    disease free survival at 3 years

Secondary outcomes

  1. 3-year recurrence rate (including pelvic recurrence rate)

    Time frame: 36 months after surgery

  2. 3-year overall survival

    Time frame: 36 months after surgery

  3. intra-operative and post-operative complications

    Time frame: 36 months after surgery

  4. Rate of upstage after surgery

    Time frame: 36 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Pavone, MD

CONTACT

[email protected]

0630155629

Nicolò Bizzarri, MD

CONTACT

[email protected]

0630155629

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: LASH

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
May 16, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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