Clinical trial NCT06832397: Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Patients With Locally Advanced Cervical Carcinoma
Official title: Prospective Observational Study On the Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Specific Subgroups of Patients With Locally Advanced Cervical canceR
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Keywords: Cervical cancer
Minimally invasive surgery in cervical cancer
Peritoneal metastases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed locally advanced cervical cancer at high risk of 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of peritoneal metastasis
timeFrame: 36 months after treatment
Secondary outcomes:
measure: 3y-DFS
timeFrame: 36 months after treatment
measure: 3y-OS
timeFrame: 36 months after treatment
measure: Response rate to CT-RT
timeFrame: 36 months after treatment
measure: Response rate to CHT
timeFrame: 36 months after treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Nicolò Bizzarri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Giovanni Scambia, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Gabriella Ferrandina, Prof.
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Matteo Bruno, MD
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Matteo Pavone, MD
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
name: Davide Arrigo, MD
role: STUDY_CHAIR
References:
citation: Bizzarri N, Pedone Anchora L, Teodorico E, Certelli C, Galati G, Carbone V, Gallotta V, Naldini A, Costantini B, Querleu D, Fanfani F, Fagotti A, Scambia G, Ferrandina G. The role of diagnostic laparoscopy in locally advanced cervical cancer staging. Eur J Surg Oncol. 2024 Dec;50(12):108645. doi: 10.1016/j.ejso.2024.108645. Epub 2024 Aug 26.
citation: de Foucher T, Bendifallah S, Ouldamer L, Bricou A, Lavoue V, Varinot J, Canlorbe G, Carcopino X, Raimond E, Monnier L, Graesslin O, Touboul C, Collinet P, Neveu ME, Huchon C, Darai E, Ballester M; Groupe de Recherche Francogyn, France. Patterns of recurrence and prognosis in locally advanced FIGO stage IB2 to IIB cervical cancer: Retrospective multicentre study from the FRANCOGYN group. Eur J Surg Oncol. 2019 Apr;45(4):659-665. doi: 10.1016/j.ejso.2018.11.014. Epub 2018 Dec 30.
citation: Marnitz S, Kohler C, Roth C, Fuller J, Hinkelbein W, Schneider A. Is there a benefit of pretreatment laparoscopic transperitoneal surgical staging in patients with advanced cervical cancer? Gynecol Oncol. 2005 Dec;99(3):536-44. doi: 10.1016/j.ygyno.2005.07.005. Epub 2005 Aug 29.
citation: Tewari KS, Sill MW, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, DiSaia PJ, Copeland LJ, Creasman WT, Stehman FB, Brady MF, Burger RA, Thigpen JT, Birrer MJ, Waggoner SE, Moore DH, Look KY, Koh WJ, Monk BJ. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017 Oct 7;390(10103):1654-1663. doi: 10.1016/S0140-6736(17)31607-0. Epub 2017 Jul 27.
citation: Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.