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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Cervical Cancer

Treatments: Procedure: Diagnostic laparoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT06832397

7386

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

LACC patients with high-risk of peritoneal metastasis

Description:

Locally advanced cervical cancer patients with high-risk of peritoneal metastasis (AJCC stage T3/T4; grade 3 cervical cancer. all histotypes; FIGO stage IIIC2).

Treatment:

Procedure: Diagnostic laparoscopy