International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Study Overview
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Brief Summary
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Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

Detailed Description
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All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned. The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia. The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board. An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

Official Title
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Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

Conditions
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Ascites, Peritoneum Cancer, Peritoneum Neoplasm, Pleural Cancer, Pleural Effusion, Pleural Mesothelioma, Ovarian Cancer, Gastric Cancer, Appendix Cancer, Pseudomyxoma Peritonei, Colorectal Cancer, Pancreas Cancer, Gallbladder Cancer, CUP, Chemotherapeutic Toxicity

Intervention / Treatment
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* Combination Product: PIPAC


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: verified peritoneal metastasis colorectal cancer ovarian cancer gastric cancer appendical cancer pseudomyxoma peritonei malignant mesothelioma pancreatic cancer gallbladder cancer small bowel cancer Exclusion criteria - bowel obstruction

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: PIPAC|A chemotherapeutic solution is aerosolized into the expanded abdominal cavity during laparoscopy, under pressure. This allows a relatively homogeneous repartition of the drug and an effective tissue penetration.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Kaplan-Meier | 1 to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate | according to RECIST criteria (CR + PR + SD) | 3 months | 
| Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) | according to the Peritoneal Regression Grading Score (PRGS) | 6 weeks | 
| Safety according to CTCAE 4.0 | according to CTCAE 4.0 | 6 weeks | 
| Quality of life according to QLQ-30 of EORTC | according to QLQ-30 of EORTC | 6-18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PITAC, Cisplatin, Oxaliplatin, Gemcitabine, Paclitaxel, nab-Paclitaxel, Doxorubicine, Mitomycin, Pressurized IntraPeritoneal Aerosol Chemotherapy, PIPAC, Pressurized IntraThoracic Aerosol Chemotherapy