Clinical trial · Observational
Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Patients With Locally Advanced Cervical Carcinoma
Prospective Observational Study On the Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Specific Subgroups of Patients With Locally Advanced Cervical canceR
NCT06832397CI-TRIAL-00086148SOLARnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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).
- interventionNames
- Procedure: Diagnostic laparoscopy
Primary outcomes (1)
- measure
- Prevalence of peritoneal metastasis
- timeFrame
- 36 months after treatment
- description
- Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy
Secondary outcomes (4)
- measure
- 3y-DFS
- timeFrame
- 36 months after treatment
- description
- 3 years disease free-survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBizzarri 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
- BACKGROUNDde 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. PMID 30685326
- BACKGROUNDMarnitz 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
- BACKGROUNDTewari 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. PMID 28756902
- BACKGROUNDMonk 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.