NCT07514494RecruitingPhase 2
Intensification Treatment of Ovarian Cancer by PIPAC
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)
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- Apr 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Moscow Regional Oncological Dispensary
- Diseases
- Ovarian cancer
- NCT number
- NCT07514494
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From Apr 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant disease in exacerbation or decompensation.
Other illness
- 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.
- Any condition precluding safe PIPAC or protocol execution, including hollow-organ perforation, gastrointestinal resection with anastomosis, or repair of a hollow-viscus defect.
Age
- Age \> 75 years; ECOG 3-4; cachexia with BMI \<= 16.
Other
- Extra-abdominal metastases, including metastatic pleuritis.
- Pregnancy or breastfeeding.
- Positive BRCA1 or BRCA2 status.
- Refusal of treatment at any study stage.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moscow Regional Oncological Dispensary Coordinator of this site? Confirm its status | Balashikha | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.