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NCT Number: NCT06832397

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Policlinico Agostino Gemelli IRCCS

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic laparoscopy

Procedure

Diagnostic laparoscopy with peritoneal biopsies

Primary outcomes

  1. Prevalence of peritoneal metastasis

    Time frame: 36 months after treatment

    Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy

Secondary outcomes

  1. 3y-DFS

    Time frame: 36 months after treatment

    3 years disease free-survival

  2. 3y-OS

    Time frame: 36 months after treatment

    3 years overall survival

  3. Response rate to CT-RT

    Time frame: 36 months after treatment

    Response rate to exclusive chemo-radiotherapy if IVA FIGO stage disease (only pelvic peritoneal disease, assessed by histological examination)

  4. Response rate to CHT

    Time frame: 36 months after treatment

    Response rate to chemo-immunotherapy if IVB FIGO stage disease (upper abdomen peritoneal disease, assessed by histological examination)

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Arrigo, MD

CONTACT

[email protected]

0630155629

Nicolò Bizzarri, MD

CONTACT

[email protected]

0630155629

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SOLAR

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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