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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Diagnostic laparoscopy
  Diagnostic laparoscopy with peritoneal biopsies

Первичные конечные точки

• Prevalence of peritoneal metastasis [Срок оценки: 36 months after treatment]

Вторичные конечные точки (4)

• 3y-DFS [Срок оценки: 36 months after treatment]
• 3y-OS [Срок оценки: 36 months after treatment]
• Response rate to CT-RT [Срок оценки: 36 months after treatment]
• Response rate to CHT [Срок оценки: 36 months after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Patients with previous diagnosis of other cancers
• Performance status ECOG >2
• Pregnant women
• Contraindications to diagnostic laparoscopy
• Recurrent cervical cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Policlinico Agostino Gemelli IRCCS — Rome

Публикации

• 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. PMID 39214031
• 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 PMID 30685326
• 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. PMID 16126259
• 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 (G PMID 28756902
• 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 Resul PMID 37910822

Идентификаторы

NCT: NCT06832397 · 7386

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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