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

• Conditions: Pleural Cancer; Pleural Mesothelioma; Appendix Cancer; Peritoneum Cancer; Pleural Effusion; Gastric Cancer; Colorectal Cancer; Ascites; Peritoneum Neoplasm; Ovarian Cancer

• Registration Number: NCT03210298
• Lead Sponsor: Sabine Rhode

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).

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-08
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	1 to 5 years	Kaplan-Meier

Secondary Outcome Measures

Name	Time	Method
Safety according to CTCAE 4.0	6 weeks	according to CTCAE 4.0
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)
Quality of life according to QLQ-30 of EORTC	6-18 weeks	according to QLQ-30 of EORTC

Trial Locations

Locations (15)

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Australia

Centre du Cancer; 🇫🇷 Montpellier, France

Roffo Cancer Institute; 🇦🇷 Buenos Aires, Argentina

SALK - Salzburger Landeskliniken; 🇦🇹 Salzburg, Austria

University Hospital Gent (UZ Gent); 🇧🇪 Gent, Belgium

University Hospital Odense; 🇩🇰 Odense, Denmark

Centre Hospitalier Universitaire; 🇫🇷 Lille, France

Hospices civils de Lyon; 🇫🇷 Lyon, France

University Hospital Tübingen; 🇩🇪 Tübingen, Germany

IRCC Torino Candiolo; 🇮🇹 Turin, Italy

F. Łukaszczyk Oncology Centre; 🇵🇱 Bydgoszcz, Poland

Gersten Institute for Cancer Research; 🇷🇺 Moscow, Russian Federation

National University Hospital; 🇸🇬 Singapore, Singapore

University Hospital Lausanne CHUV; 🇨🇭 Lausanne, Switzerland

Hospital de Pilar; 🇪🇸 Barcelona, Spain