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Intensification Treatment of Ovarian Cancer by PIPAC

NCT07514494 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-07

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether repeated cisplatin-based PIPAC added to standard TC chemotherapy can improve outcomes in women aged 18-75 years with newly diagnosed FIGO IIIB-IIIC epithelial ovarian cancer and visually detectable peritoneal carcinomatosis. The main questions are whether repeated PIPAC increases the rate of complete surgical cytoreduction (CRS R0) and whether it improves disease control, survival outcomes, and safety compared with standard combined treatment including a single PIPAC procedure. Participants will undergo screening, intraoperative randomization, systemic chemotherapy, PIPAC procedures according to study arm, interval cytoreductive surgery, protocol-specified postoperative treatment if needed, and regular follow-up assessments.

Conditions

  • Advanced Epithelial Ovarian Cancer
  • Peritoneal Carcinomatosis

Interventions

PROCEDURE

PIPAC

Performed laparoscopically under general anesthesia. Drug: cisplatin 30 mg/m² diluted in 180 mL normal saline Administration: * Capnoperitoneum established with carbon dioxide at a target pressure of 12-14 mmHg. * Flow settings depend on nozzle size: No. 150, 0.3-0.4 mL/s; No. 200, 0.7-0.8 mL/s. * Nebulizer selection depends on patient height and body-mass index; tense ascites is evacuated before treatment. * The aerosol flow is directed toward the largest free intraperitoneal space and away from hollow viscera, ligated vessels, and tumor beds. * Exposure time is maintained for exactly 30 minutes. * The abdomen is decompressed without aspirating the cytostatic solution, and no drain is left in place.

Sponsors & Collaborators

  • Moscow Regional Oncological Dispensary

    lead OTHER_GOV

Principal Investigators

  • Alexey S. Dzasokhov, MD, PhD · Moscow Regional Oncological Dispensary

  • Sergei O. Gunyakov · Moscow Regional Oncological Dispensary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2026-10-02
Completion
2030-04-02

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514494 on ClinicalTrials.gov