Minimally invasive simple hysterectomy for low-risk cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety of performing a minimally invasive simple hysterectomy in patients with low-risk early-stage cervical cancer, specifically those meeting the inclusion criteria of the SHAPE trial. The SHAPE trial indicated that simple hysterectomy could be a viable alternative to radical hysterectomy without compromising oncological outcomes. The current trial aims to further investigate the safety of this surgical approach, given the favorable outcomes observed in previous studies. Participants will undergo laparoscopic surgery to assess the effectiveness and safety of this method.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Roma, Italy Recruiting

Study contacts

• Study coordinator: Nicolò Bizzarri, MD
• Email: nicolo.bizzarri@yahoo.com
• Phone: 0630155629

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How cinema sessions during chemotherapy might help cervical cancer patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.