Repeated PIPAC plus standard platinum–taxane chemotherapy for advanced ovarian cancer with peritoneal spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, prospective, randomized, open‑label trial compares repeated cisplatin‑based PIPAC given at predefined operative stages plus standard carboplatin–paclitaxel (TC) systemic chemotherapy versus a strategy with a single PIPAC at interval cytoreductive surgery. Eligible women undergo screening and intraoperative randomization, receive systemic chemotherapy and PIPAC according to their assigned arm, then undergo interval cytoreductive surgery followed by protocol‑specified postoperative treatment and regular follow‑up. PIPAC is delivered laparoscopically as a pressurized intraperitoneal aerosol intended to improve spatial drug distribution and tissue penetration while limiting systemic exposure. The trial’s main goals are to increase the rate of complete surgical cytoreduction (CRS R0) and to compare disease control, survival outcomes, and safety between the repeated and single PIPAC strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female, age 18-75 years.
* Histologically verified ovarian cancer with peritoneal carcinomatosis.
* FIGO stage IIIB or IIIC.
* visually detectable peritoneal carcinomatosis.
* Peritoneal metastatic involvement documented preoperatively by ultrasound, CT, MRI, PET-CT, or equivalent imaging.
* Ability to comply with protocol procedures and provide written informed consent.

Exclusion Criteria:

* Age \> 75 years; ECOG 3-4; cachexia with BMI \<= 16.
* Severe concomitant disease in exacerbation or decompensation.
* Extra-abdominal metastases, including metastatic pleuritis.
* Mucinous ovarian carcinoma or another active malignant neoplasm, except malignancies in clinical remission for more than 2 years.
* Pronounced adhesive disease of the abdominal cavity.
* Pregnancy or breastfeeding.
* Positive BRCA1 or BRCA2 status.
* Any condition precluding safe PIPAC or protocol execution, including hollow-organ perforation, gastrointestinal resection with anastomosis, or repair of a hollow-viscus defect.
* Refusal of treatment at any study stage.

Where it's running

• Moscow Regional Oncological Dispensary
  Balashikha, Russia Recruiting

Study contacts

• Principal investigator: Alexey S. Dzasokhov, MD, PhD — Moscow Regional Oncological Dispensary
• Study coordinator: Alexey S. Dzasokhov, MD, PhD
• Email: dzasokhov-pipac@mail.ru
• Phone: +79295596135

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.