Cervical Cancers, Vaginal Cancers
Conditions
Keywords
cervical cancer, vaginal cancer, minimally invasive surgery, pelvic exenteration, gynecologic oncology
Brief summary
The aim of this clinical trial is to assess the oncologic safety of minimally invasive pelvic exenteration in patients with recurrence or persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). The primary aim is to assess the 3-year disease-free survival (DFS). The secondary aim is to assess the 3-year overall survival (OS), the intraoperative and post-operative complication rate, and the patient's quality of life.
Detailed description
Patients will be considered pre-operatively eligible in case of recurrence/persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). Histological diagnosis of recurrent or persistent disease obtained with biopsy performed during examination under anesthesia or US-guided biopsy, or RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria of progressive disease are required, as by standard clinical practice. All patients will undergo MRI pelvic scan and PET/CT scan within one month before the surgery, as by standard clinical practice. After obtaining oral and written informed consent, patients will be registered. Pelvic exenteration will be performed with the aim of removing a single specimen with negative surgical margins. A mini-laparotomy of up to 7 cm will be allowed to complete the reconstructive phase of the procedure. Registration data has to be entered to an electronic Case Report Form (eCRF). The Principal Investigator (PI) of the study will independently take responsibility for the development of an electronic Case Report Form (CRF) for data collection.
Interventions
PROCEDUREMinimally invasive pelvic exenteration
If all criteria are met, patients are registered. The patient is enrolled before the surgery, at the time of pelvic evaluation under anaesthesia. A diagnostic laparoscopic assessment can be performed before the operation to exclude peritoneal metastasis. The experimental procedure in this protocol involves the use of a minimally invasive approach (robot-assisted or laparoscopic) for performing pelvic exenteration.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of recurrent or persistent vaginal or cervical cancer * Proven histological diagnosis of squamous carcinoma, adenocarcinoma or adenosquamous carcinoma * Isolated central pelvic recurrence * MRI-measured maximum tumor diameter ≤ 50 mm * Age \> 18 years * Patients who have signed an approved informed consent form * Patients must be suitable for surgery * ECOG Performance Status of 0, 1 or 2 (Eastern Cooperative Oncology Group)
Exclusion criteria
* Para-aortic lymph nodes with a short-axis diameter ≥ 15 mm on MRI scan and/or SUV max ≥ 2.5 on PET/CT scan * Involvement of lateral pelvic structures (on preoperative imaging or during examination under anaesthesia) * Sciatic nerve involvement (at pre-operative imaging or during examination under anaesthesia) * Distant metastasis at PET/CT scan * Any histological type other than squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma * Contraindications to surgery * Serious concomitant systemic disorders incompatible with surgery or minimally invasive surgery (at the discretion of the investigator) * Women unable to tolerate prolonged lithotomy and steep Trendelenburg positions * Women with secondary invasive neoplasm in the last 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | From the enrollment for the following three years. | The primary aim is to assess the 3-year disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Survival time is calculated from the date of surgery until the date of death from any cause, or for patients still alive to the date of last clinical follow-up or contact, assessed up to 100 months. | One of the secondary aim is to assess the overall survival. |
| Intraoperative complication rate | During the procedure | Intraoperative complications will be assessed with CTCAE 5.0 classification (Common Terminology Criteria for Adverse Events). |
| Post-operative complication rate | One month and six months after surgery | Post-operative complications: will be assessed with Clavien-Dindo classification |
| Health Related Quality of Life (HRQoL) n.1 | At baseline and one month, six months, one years and two years after surgery. | Quality of life will be assessed by questionnaires completed by study participants preferably as electronical patient reported outcome measures or during the clinic visit. Questionnaire n. 1 comprises the EORTC QLQ-30 (version 3.0, EORTC: European Organization for Research and Treatment of Cancer; QLQ: Quality-of-Life questionnaire). |
| Health Related Quality of Life (HRQoL) n. 2 | At baseline and one month, six months, one years and two years after surgery. | Quality of life will be assessed by questionnaires completed by study participants preferably as electronical patient reported outcome measures or during the clinic visit. Questionnaire n. 2 comprises the EORTC QLQCX24 (European Organization for Research and Treatment of Cancer; QLQ: Quality-of-Life questionnaire) |
Countries
Italy
Contacts
Primary ContactNicolò Bizzarri
Outcome results
None listed