RecruitingNot ApplicableNCT06416748

Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

974 participants

Start Date

Oct 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a minimally invasive (laparoscopic or robotic) hysterectomy — removal of the uterus — is a safe alternative to open surgery for women with low-risk early-stage cervical cancer. Traditional guidelines have shifted toward open surgery, but this trial seeks to define a low-risk group where less invasive surgery is still safe. **You may be eligible if...** - You are 18 or older - You have been diagnosed with cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer is early-stage (FIGO 2018 stage IA2–IB1) with a tumor no larger than 2 cm - The depth of cancer invasion is no more than 10mm (confirmed by cone biopsy or imaging) - You have not had prior pelvic radiotherapy **You may NOT be eligible if...** - Your tumor is larger than 2 cm - The cancer has invaded more than 10 mm deep or more than 50% of the cervical wall - You have a rare cancer type (neuroendocrine, clear cell, or serous) - You are pregnant or wish to preserve your fertility - You have had previous pelvic radiation - Your cancer has come back (recurrent cervical cancer) - More than 4 months have passed since diagnosis if your surgical margins were clear Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMinimally 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.


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

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NCT06416748


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