Intensification Treatment of Ovarian Cancer by PIPAC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMoscow Regional Oncological Dispensary

About this trial

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 criteria

Qualifiers

Female, age 18-75 years.

Histologically verified ovarian cancer with peritoneal carcinomatosis.

FIGO stage IIIB or IIIC.

visually detectable peritoneal carcinomatosis.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PIPAC

Treatment groups

160 Participants
are divided into 3 treatment groups