Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT07514494

Intensification Treatment of Ovarian Cancer by PIPAC

Led by Moscow Regional Oncological Dispensary · Updated on 2026-04-07

160

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Intensification Treatment of Ovarian Cancer by PIPAC

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, age 18-75 years
  • Histologically verified ovarian cancer with peritoneal carcinomatosis
  • FIGO stage IIIB or IIIC
  • Visually detectable peritoneal carcinomatosis
  • Peritoneal metastatic involvement confirmed by imaging (ultrasound, CT, MRI, PET-CT, or equivalent)
  • Ability to comply with study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Age over 75 years
  • ECOG performance status 3-4
  • Cachexia with BMI 16 or lower
  • Severe worsening or decompensated concomitant disease
  • Presence of extra-abdominal metastases, including metastatic pleuritis
  • Mucinous ovarian carcinoma or other active malignant tumors except those in remission over 2 years
  • Significant adhesive disease in the abdominal cavity
  • Pregnancy or breastfeeding
  • Positive BRCA1 or BRCA2 genetic status
  • Conditions preventing safe PIPAC or protocol adherence, including hollow-organ perforation or recent gastrointestinal surgery
  • Refusal of treatment at any stage of the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Moscow Regional Oncological Dispensary

Balashikha, Russia, 14390

Actively Recruiting

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Research Team

A

Alexey S. Dzasokhov, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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