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

NCT06832397 | Not Yet Recruiting DMC

• 1 other identifier: 7386
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Cervical cancer; Minimally invasive surgery in cervical cancer; Peritoneal metastases

Outcome Measures

Primary Outcomes (1)

• Prevalence of peritoneal metastasis

  Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy

  36 months after treatment

Secondary Outcomes (4)

• 3y-DFS

  36 months after treatment

• 3y-OS

  36 months after treatment

• Response rate to CT-RT

  36 months after treatment

• Response rate to CHT

  36 months after treatment

Study Arms (1)

LACC patients with high-risk of peritoneal metastasis

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

Interventions

Diagnostic laparoscopy PROCEDURE

Diagnostic laparoscopy with peritoneal biopsies

LACC patients with high-risk of peritoneal metastasis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients meeting the inclusion criteria
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed locally advanced cervical cancer at high risk of peritoneal metastases.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Agostino Gemelli IRCCS

Rome, Italy

Location

Related Publications (5)

• 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 BACKGROUND

• 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.

  PMID: 30685326 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28756902 BACKGROUND

• 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.

  PMID: 37910822 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nicolò Bizzarri, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

  PRINCIPAL INVESTIGATOR

• Giovanni Scambia, Prof.

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

  STUDY CHAIR

• Gabriella Ferrandina, Prof.

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

  STUDY CHAIR

• Matteo Bruno, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

  STUDY CHAIR

• Matteo Pavone, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

  STUDY CHAIR

• Davide Arrigo, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

  STUDY CHAIR

Central Study Contacts

Nicolò Bizzarri, MD

CONTACT

0630155629; nicolo.bizzarri@yahoo.com

Davide Arrigo, MD

CONTACT

0630155629; davidearrigo.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

IT (1)