Minimally Invasive Simple Hysterectomy for Low-Risk Early Cervical Cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 or older with early-stage, low-risk cervical cancer who are having a simple hysterectomy by minimally invasive surgery.

Age

18 years or older

Sex

Women only

Disease stage

Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO 2018 stage IA2-IB1 (≤2cm (0.8 in)), with depth of infiltration ≤10mm on the conization specimen or ≤50% on pre-conization MRI or expert ultrasound.

Earlier treatment

Cannot have had neoadjuvant chemotherapy or previous pelvic radiotherapy.

Main reasons for not taking part

• Neuroendocrine, clear cell or serous carcinoma
• Cervical tumor >2 cm (0.8 in) or depth of infiltration >10 mm on conization or >50% on imaging
• Pregnant women
• Lymph nodes >15 mm short axis
• Fertility sparing treatment or desire, or recurrent cervical cancer

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• single armOther group

  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.

  Treatment: Minimally invasive simple hysterectomy