Repeated PIPAC plus standard platinum–taxane chemotherapy for advanced ovarian cancer with peritoneal spread
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) as a Component of Combined Treatment in Patients With Advanced Epithelial Ovarian Cancer and Peritoneal Carcinomatosis: A Randomized Phase II Trial (PrimPIPAC)
This test sees if adding repeated cisplatin-based PIPAC to standard platinum–taxane chemotherapy helps women aged 18–75 with newly diagnosed FIGO IIIB–IIIC epithelial ovarian cancer and visible peritoneal carcinomatosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Moscow Regional Oncological Dispensary Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Balashikha) |
| Trial ID | NCT07514494 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–75 with newly diagnosed FIGO IIIB–IIIC epithelial ovarian cancer and visually detectable peritoneal carcinomatosis who are fit for systemic platinum‑taxane chemotherapy and laparoscopic procedures.
Not a fit: Patients with extra‑abdominal metastases, mucinous ovarian carcinoma, positive BRCA1/2 status, poor performance status, pronounced adhesive disease, or those who cannot safely undergo laparoscopy or repeated intraperitoneal procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could increase the chances of complete surgical tumor removal in the abdomen and improve disease control and survival.
How similar studies have performed: PIPAC has shown promising safety and local disease‑control signals in small and early‑phase studies of peritoneal metastases, but randomized data in first‑line ovarian cancer remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Balashikha
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.