Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to perform surgery for women with low-risk early-stage cervical cancer. Specifically, it is studying whether a less invasive surgery, called a minimally invasive simple hysterectomy, can be safely done instead of a more extensive surgery known as radical hysterectomy. The trial wants to ensure that this gentler approach is safe for patients who meet certain criteria, as previous research showed good results with the minimally invasive method even though it wasn't the main focus of that study.

To be eligible for this trial, participants must be women aged 18 and older who have specific types of cervical cancer (like squamous cell carcinoma or adenocarcinoma) at an early stage. They should have tumors that are small (2 cm or less) and not too deep (less than 10 mm) in the tissue. If you join the trial, you can expect to undergo this surgery and receive follow-up care to monitor your recovery. It's important to note that there are certain conditions that would exclude someone from participating, such as larger tumors or previous treatment for cancer. Overall, this study aims to provide more options for women with early-stage cervical cancer while keeping their safety a top priority.

Gender

FEMALE

Eligibility criteria

• 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