Minimally invasive simple hysterectomy for low-risk cervical cancer
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
This study is testing if a less invasive surgery called a simple hysterectomy is safe for women with low-risk early-stage cervical cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 974 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Trial ID | NCT06416748 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with low-risk cervical cancer (FIGO stage IA2-IB1) who meet specific criteria regarding tumor size and depth of infiltration.
Not a fit: Patients with higher-risk cervical cancer, those requiring radical hysterectomy, or those with contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and less invasive surgical option for patients with low-risk cervical cancer, potentially improving recovery times and quality of life.
How similar studies have performed: Previous studies, such as the SHAPE trial, have shown promising results for simple hysterectomy in low-risk cervical cancer, but the specific minimally invasive approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Nicolò Bizzarri, MD
- Email: nicolo.bizzarri@yahoo.com
- Phone: 0630155629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.