Appendix Cancer, Ascites, Chemotherapeutic Toxicity, Colorectal Cancer, CUP, Gallbladder Cancer, Gastric Cancer, Ovarian Cancer, Pancreas Cancer, Peritoneum Cancer, Peritoneum Neoplasm, Pleural Cancer, Pleural Effusion, Pleural Mesothelioma, Pseudomyxoma Peritonei
Conditions
Keywords
Pressurized IntraPeritoneal Aerosol Chemotherapy, PIPAC, Pressurized IntraThoracic Aerosol Chemotherapy, PITAC, Cisplatin, Oxaliplatin, Gemcitabine, Paclitaxel, nab-Paclitaxel, Doxorubicine, Mitomycin
Brief summary
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
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).
Interventions
COMBINATION_PRODUCTPIPAC
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.
Sponsors
Ruhr University of Bochum
Sabine Rhode
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 to 5 years | Kaplan-Meier |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Rate | 3 months | according to RECIST criteria (CR + PR + SD) |
| Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) | 6 weeks | according to the Peritoneal Regression Grading Score (PRGS) |
| Safety according to CTCAE 4.0 | 6 weeks | according to CTCAE 4.0 |
| Quality of life according to QLQ-30 of EORTC | 6-18 weeks | according to QLQ-30 of EORTC |
Countries
Argentina, Australia, Austria, Belgium, Denmark, France, Germany, Italy, Poland, Russia, Singapore, Spain, Switzerland
Contacts
Primary ContactSabine Rhode
Outcome results
None listed