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PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

ConditionsEarly Stage Ovarian TumorsPeritoneal Carcinosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOspedale Santa Croce-Carle Cuneo

About this trial

Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors

Complete preoperative work-up (ultrasound, CT scan, tumor markers)

Laparoscopic, robotic or open surgical approach

Disqualifiers

Sarcomas, melanomas, mesotheliomas, hematologic malignancies

Advanced ovarian tumors

Fertility-sparing surgery with uterine preservation

Inability to provide informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach

    Procedure/Surgery

    Surgical Procedure: Initial step: Exclude upper abdominal disease through inspection and guideline-based biopsies. Pelvic peritoneal resection: En bloc or segmental removal of predefined pelvic peritoneal regions according to dissection of retroperitoneal spaces with a nerve-sparing technique.

  • Histopathologic Analysis

    Diagnostic test

    Fixation: 10% neutral-buffered formalin for 6-48 hours. Processing: Paraffin eembedding and complete sampling for histology. Staining: H\&E and immunohistochemistry (MOC-31, BER-EP4) to identify epithelial tumor cells. Reporting: Checklist for peritoneal disease

Treatment groups

390 Participants
are divided into 1 treatment group
Group A: Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasmaOther 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).

Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)

Time frame
from surgery up to at least 24 months of follow up after surgery

Secondary outcomes

1

Perioperative complications

Clavien-Dindo classification

Time frame
from the date of surgery up to six months after surgery
2

Recurrence site

Time frame
from the date of surgery up to at least 24 months of follow up
3

2-year progression free survival

Time frame
24 months after surgery
4

2-year overall survival

Time frame
24 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ospedale Santa Croce-Carle Cuneo

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: