Intensification Treatment of Ovarian Cancer by PIPAC

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.

Eligibility

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.

Conditions3

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