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)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Russian Federation
Moscow Regional Oncological Dispensary
RECRUITING
Balashikha
Contact Information
Primary
Alexey S. Dzasokhov, MD, PhD
dzasokhov-pipac@mail.ru
+79295596135
Time Frame
Start Date:2025-04-02
Estimated Completion Date:2030-04-02
Participants
Target number of participants:160
Treatments
Experimental: Test group with 3 PIPAC procedures
Participants undergo a multimodal treatment sequence consisting of diagnostic laparoscopy with multifocal peritoneal biopsy, repeated PIPAC procedures, systemic TC chemotherapy, and cytoreductive surgery. At Visit 1, participants receive diagnostic laparoscopy, multifocal peritoneal biopsy, the first PIPAC session, and the first cycle of intravenous TC chemotherapy. Visit 2 includes the second cycle of intravenous TC chemotherapy. At Visit 3, participants undergo the second PIPAC session and receive the third cycle of TC chemotherapy. At Visit 4, participants undergo cytoreductive surgery (CRS), the third PIPAC session, and the fourth cycle of intravenous TC chemotherapy. In patients achieving complete cytoreduction (CRS R0), treatment is followed by Visits 5 and 6, corresponding to the fifth and sixth cycles of TC chemotherapy.
Active_comparator: Control group with 1 PIPAC procedure
Participants undergo a multimodal treatment sequence consisting of diagnostic laparoscopy with multifocal peritoneal biopsy, systemic TC chemotherapy, cytoreductive surgery, and a single PIPAC procedure. At Visit 1, participants undergo diagnostic laparoscopy, multifocal peritoneal biopsy, and receive the first cycle of intravenous TC chemotherapy. Visit 2 includes the second cycle of intravenous TC chemotherapy. At Visit 3, participants receive the third cycle of TC chemotherapy. At Visit 4, participants undergo cytoreductive surgery (CRS), a single PIPAC procedure, and the fourth cycle of intravenous TC chemotherapy. In patients achieving complete cytoreduction (CRS R0), treatment is continued with Visits 5 and 6, corresponding to the fifth and sixth cycles of TC chemotherapy.
Active_comparator: Crossover group with additional PIPAC
Participants from either randomized arm who have incomplete cytoreduction (CRS R2) at Visit 4 enter a crossover treatment branch. After cytoreductive surgery, treatment is continued with postoperative TC chemotherapy. At Visit 5, participants receive the fifth cycle of intravenous TC chemotherapy. At Visit 6, participants undergo one additional PIPAC procedure followed by the sixth cycle of intravenous TC chemotherapy. This crossover branch is intended for participants in whom complete cytoreduction is not achieved.