Clinical trial · Observational
Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)
Evaluation of Molecular and Pathophysiological Mechanisms of Peritoneal Carcinomatosis and Monitoring of the Efficiency of PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) as a Local Chemotherapeutical Treatment.
- 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 study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIPAC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient with peritoneal carcinomatosis
- description
- Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed.
- interventionNames
- Procedure: PIPAC
Primary outcomes (1)
- measure
- Overall Survival (years)
- timeFrame
- 5 years
Secondary outcomes (3)
- measure
- The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments
- timeFrame
- 25 weeks
- measure
- Overall Response Rate (CT RESIST criteria)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors * Age \> 18 years * signed informed consent Exclusion Criteria: * Patient can not understand meaning and purpose of the study
References
Publications (3)
- DERIVEDJansen-Winkeln B, Eberth J, Moulla Y, Mehdorn M, Niebisch S, Schierle K, Blaker H, Lordick F, Gockel I, Thieme R. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal surface malignancies (PSM): a prospective single-center registry study. J Cancer Res Clin Oncol. 2023 Mar;149(3):1331-1341. doi: 10.1007/s00432-022-04517-w. Epub 2022 Dec 13. PMID 36513815
- DERIVEDGockel I, Jansen-Winkeln B, Haase L, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer. Tumori. 2020 Feb;106(1):70-78. doi: 10.1177/0300891619868013. Epub 2019 Aug 30. PMID 31469058
- DERIVEDGockel I, Jansen-Winkeln B, Haase L, Rhode P, Mehdorn M, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Cancer Patients with Peritoneal Metastasis (PM): Results of a Single-Center Experience and Register Study. J Gastric Cancer. 2018 Dec;18(4):379-391. doi: 10.5230/jgc.2018.18.e37. Epub 2018 Dec 14. PMID 30607301