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.
|First Received Date||June 29, 2017|
|Last Changed Date||July 10, 2017|
|Start Date||January 2016|
|Anticipated Primary Completion Date||May 2018|
|Primary Outcome Measures||
Overall survival [Time Frame: 1 to 5 years]
|Secondary Outcome Measures||
Clinical Benefit Rate [Time Frame: 3 months]
Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) [Time Frame: 6 weeks]
Safety according to CTCAE 4.0 [Time Frame: 6 weeks]
Quality of life according to QLQ-30 of EORTC [Time Frame: 6-18 weeks]
|Study Type||Observational [Patient Registry]|
|Study Arms / Comparison Groups||0 / 1|
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).
|Ages||10 Years - N/A|
|Accepts Healthy Volunteers||No|
Phone: +49 391 67 17960
- verified peritoneal metastasis
- colorectal cancer
- ovarian cancer
- gastric cancer
- appendical cancer
- pseudomyxoma peritonei
- malignant mesothelioma
- pancreatic cancer
- gallbladder cancer
- small bowel cancer
- bowel obstruction
|Verification Date||July 2017|