Cervical Cancer, Cervix Cancer
Conditions
Keywords
Cervical cancer, Minimally invasive surgery in cervical cancer, Robotic surgery in cervical cancer, Laparoscopic surgery in cervical cancer, LACC trial, SHAPE trial, Low risk cervical cancer
Brief summary
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.
Detailed description
The Laparoscopic Approach to Cervical Cancer (LACC) Trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. Since then, the standard of care in terms of surgical approach to radical hysterectomy has been considered the laparotomy. More recently, the SHAPE trial results were presented showing that in patients with low-risk cervical cancer (defined as FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on MRI) simple hysterectomy was not inferior to radical hysterectomy for what concerned pelvic recurrence, with less complications and better quality of life. However, SHAPE trial was not designed to assess the surgical approach. 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.
Interventions
PROCEDUREMinimally invasive simple hysterectomy
Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: &lt; 10 mm on LEEP/cone and &lt; 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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 \>2/3.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year DFS | 36 months after surgery | disease free survival at 3 years |
Secondary
| Measure | Time frame |
|---|---|
| 3-year recurrence rate (including pelvic recurrence rate) | 36 months after surgery |
| 3-year overall survival | 36 months after surgery |
| intra-operative and post-operative complications | 36 months after surgery |
| Rate of upstage after surgery | 36 months after surgery |
Countries
Italy
Contacts
Primary ContactNicolò Bizzarri, MD
Backup ContactMatteo Pavone, MD
Outcome results
None listed