Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Minimally invasive simple hysterectomy
Procedure/SurgeryPatients 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 groups
974 Participants
are divided into 1 treatment groupGroup A: single armOther 1 intervention
Trial outcomes
Primary outcomes
1
3-year DFS
disease free survival at 3 years
Time frame
36 months after surgerySecondary outcomes
1
3-year recurrence rate (including pelvic recurrence rate)
Time frame
36 months after surgery2
3-year overall survival
Time frame
36 months after surgery3
intra-operative and post-operative complications
Time frame
36 months after surgery4
Rate of upstage after surgery
Time frame
36 months after surgerySponsors and contacts
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Source ClinicalTrials.gov