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

Not yet recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06832397
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2028-02
• Study Completion: 2031-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of peritoneal metastasis	36 months after treatment	Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Policlinico Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy