Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Patients With Locally Advanced Cervical Carcinoma

NCT06832397NOT_YET_RECRUITINGOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

120

Start Date

2025-02-01

Completion Date

2028-02-01

Study Type

OBSERVATIONAL

Official Title

Prospective Observational Study On the Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Specific Subgroups of Patients With Locally Advanced Cervical canceR

Interventions

Diagnostic laparoscopy

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Prevalence of peritoneal metastasis

Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy

Time frame: 36 months after treatment

Secondary Outcomes

3y-DFS

3 years disease free-survival

Time frame: 36 months after treatment

3y-OS

3 years overall survival

Time frame: 36 months after treatment

Response rate to CT-RT

Response rate to exclusive chemo-radiotherapy if IVA FIGO stage disease (only pelvic peritoneal disease, assessed by histological examination)

Time frame: 36 months after treatment

Response rate to CHT

Response rate to chemo-immunotherapy if IVB FIGO stage disease (upper abdomen peritoneal disease, assessed by histological examination)

Time frame: 36 months after treatment

Locations

Policlinico Agostino Gemelli IRCCS, Rome, Italy

Linked Papers

2024-08-26

The role of diagnostic laparoscopy in locally advanced cervical cancer staging

Peritoneal involvement may be overlooked in patients with locally advanced cervical cancer (LACC). This may lead to underestimation of prognosis and to undertreatment limited to locoregional disease locations. However, staging laparoscopy in LACC is not routinely performed. The primary aim of this study was to determine the proportion of peritoneal metastasis by laparoscopy and the factors associated with peritoneal metastasis in patients with LACC. Secondary aims were to evaluate the performance of staging imaging in detecting peritoneal disease and the prognosis of patients with peritoneal metastasis. Retrospective single-institution study including consecutive patients with newly diagnosed LACC (FIGO 2018 stage IB3 and IIA2-IVA) between 06/2015 and 06/2020. All women underwent PET/CT scan, MRI scan and diagnostic laparoscopy at the time of examination under anesthesia (EUA), as part of cervical cancer staging. Peritoneal metastasis was histologically confirmed in all cases. 251 patients were included. 33 (13.2 %) had peritoneal metastasis. The treatment plan was changed for 28/33 (84.8 %) patients with peritoneal metastasis (11.1 % of the entire LACC cohort). Multivariate analysis demonstrated that grade 3 (OR:1.572, 95%CI:1.021-2.419; p = 0.040) and AJCC stage T3-4 (OR:3.435, 95%CI:1.482-7.960; p = 0.004) were variables associated with increased risk of peritoneal metastasis. Sensitivity of PET/CT-scan and MRI-scan in detecting peritoneal metastasis was 4.5 % (95%CI:0.1-22.8) and 13.8 % (95%CI:3.9-31.7), respectively. Peritoneal metastasis was independently associated with worse PFS and OS (HR:3.008, 95%CI:1.779-5.087, p < 0.001 and HR:4.078, 95%CI:2.232-7.451; p < 0.001, respectively). LACC patients with grade 3 histology and/or AJCC stage T3-4 had high-risk of peritoneal metastasis and diagnostic laparoscopy might be considered as part of cervical cancer staging in these patients. Peritoneal metastasis was an independent factor associated with worse PFS and OS.

Linked Investigators

Anna Fagotti

Giovanni Scambia

Nicolò Bizzarri