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.
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).
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Roffo Cancer Institute
Buenos Aires, Argentina
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Australia
RECRUITINGSALK - Salzburger Landeskliniken
Salzburg, Austria
RECRUITINGUniversity Hospital Gent (UZ Gent)
Ghent, Belgium
RECRUITINGUniversity Hospital Odense
Odense, Denmark
RECRUITINGCentre Hospitalier Universitaire
Grenoble, France
RECRUITINGCentre Hospitalier Universitaire
Lille, France
RECRUITINGHospices civils de Lyon
Lyon, France
RECRUITINGCentre du Cancer
Montpellier, France
RECRUITINGUniversity Hospital Tübingen
Tübingen, Germany
RECRUITING...and 6 more locations
Overall survival
Kaplan-Meier
Time frame: 1 to 5 years
Clinical Benefit Rate
according to RECIST criteria (CR + PR + SD)
Time frame: 3 months
Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS)
according to the Peritoneal Regression Grading Score (PRGS)
Time frame: 6 weeks
Safety according to CTCAE 4.0
according to CTCAE 4.0
Time frame: 6 weeks
Quality of life according to QLQ-30 of EORTC
according to QLQ-30 of EORTC
Time frame: 6-18 weeks
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