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

February 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy
        • Policlinico Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic laparoscopy with peritoneal biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of peritoneal metastasis
Time Frame: 36 months after treatment
Prevalence of peritoneal metastasis assessed by diagnostic laparoscopy
36 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3y-DFS
Time Frame: 36 months after treatment
3 years disease free-survival
36 months after treatment
3y-OS
Time Frame: 36 months after treatment
3 years overall survival
36 months after treatment
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)
36 months after treatment
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)
36 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Study Chair: Giovanni Scambia, Prof., Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
  • Study Chair: Gabriella Ferrandina, Prof., Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
  • Principal Investigator: Nicolò Bizzarri, MD, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7386

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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