An observational study in Cervical Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 120 is close to the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Patients with newly diagnosed locally advanced cervical cancer at high risk of peritoneal metastases.
Exclusion Criteria:
Locally advanced cervical cancer patients with high-risk of peritoneal metastasis (AJCC stage T3/T4; grade 3 cervical cancer. all histotypes; FIGO stage IIIC2).
Procedure: Diagnostic laparoscopy
Diagnostic laparoscopy with peritoneal biopsies
Prevalence of peritoneal metastasis
Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy
Time frame: 36 months after treatment
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
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS