Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Epithelial Ovarian Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIPAC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Test group with 3 PIPAC procedures
- description
- 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.
- interventionNames
- Procedure: PIPAC
- type
- ACTIVE_COMPARATOR
- label
- Control group with 1 PIPAC procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available