Cervical Cancer
Conditions
Keywords
Cervical cancer, Minimally invasive surgery in cervical cancer, Peritoneal metastases
Brief summary
The study hypothesizes that specific subgroups of LACC patients, (AJCC stage T3/T4, grade 3 tumors, and para-aortic lymph node involvement), have a higher prevalence of peritoneal metastasis. This peritoneal spread may serve as a prognostic factor, and diagnostic laparoscopy could improve staging accuracy, thereby guiding personalized treatment strategies and improving oncological outcomes.
Detailed description
Cervical cancer is the most prevalent gynecologic malignancy worldwide, with poor prognosis particularly in patients diagnosed with locally advanced cervical cancer (LACC; FIGO stage IB3-IVA). Although peritoneal metastasis is not included in FIGO staging, it is considered as a distant metastasis. Several studies have reported peritoneal disease in about 20% of LACC patients undergoing diagnostic laparoscopy, suggesting a potential role for laparoscopy in staging. However, the benefit of laparoscopy in surgical staging is controversial and the impact of peritoneal involvement on prognosis remains unclear. This is a prospective, observational, single-center study. The primary objective is to assess the prevalence of peritoneal metastasis in specific subgroups of LACC patients (AJCC stage T3/T4, grade 3 cervical cancer, FIGO stage IIIC2) using diagnostic laparoscopy. Secondary objectives include evaluating 3-year disease-free survival (DFS), overall survival (OS), and treatment response rates to exclusive chemoradiotherapy (if pelvic peritoneal involvement, FIGO IVA) and chemo-immunotherapy (if upper abdominal peritoneal involvement, FIGO IVB) in patients with peritoneal metastasis.
Interventions
PROCEDUREDiagnostic laparoscopy
Diagnostic laparoscopy with peritoneal biopsies
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cervical cancer AJCC stage T3/T4 and/or * Cervical cancer FIGO stage IB3 and IIA2-IVA grade 3 and/or * Cervical cancer FIGO stage IIIC2 (para-aortic lymph node metastasis). Lymph node will be considered pathologic when the short axis diameter is \> 10 mm at MRI scan and/or SUV max \>2.5 at PET/CT-scan. * All cervical histology sub-types will be included * Stage assessment according to local Multidisciplinary Board * Age \>18 years * Signature informed consent or substitute declaration on the consent form where applicable.
Exclusion criteria
* Patients with previous diagnosis of other cancers * Performance status ECOG \>2 * Pregnant women * Contraindications to diagnostic laparoscopy * Recurrent cervical cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of peritoneal metastasis | 36 months after treatment | Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3y-DFS | 36 months after treatment | 3 years disease free-survival |
| 3y-OS | 36 months after treatment | 3 years overall survival |
| Response rate to CT-RT | 36 months after treatment | Response rate to exclusive chemo-radiotherapy if IVA FIGO stage disease (only pelvic peritoneal disease, assessed by histological examination) |
| Response rate to CHT | 36 months after treatment | Response rate to chemo-immunotherapy if IVB FIGO stage disease (upper abdomen peritoneal disease, assessed by histological examination) |
Countries
Italy
Contacts
Primary ContactNicolò Bizzarri, MD
Backup ContactDavide Arrigo, MD
Outcome results
None listed