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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03210298
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : October 8, 2019
Ruhr University of Bochum
Information provided by (Responsible Party):
Sabine Rhode, University of Magdeburg

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.

Condition or disease Intervention/treatment
Peritoneum Cancer Peritoneum Neoplasm Pleural Cancer Pleural Effusion Pleural Mesothelioma Ovarian Cancer Gastric Cancer Appendix Cancer Pseudomyxoma Peritonei Colorectal Cancer Pancreas Cancer Gallbladder Cancer Ascites CUP Chemotherapeutic Toxicity Combination Product: PIPAC

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 (

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases
Actual Study Start Date : January 2016
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Intervention Details:
  • 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.
    Other Names:
    • PITAC
    • Intraperitoneal chemotherapy
    • Intrathoracic chemotherapy

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 to 5 years ]

Secondary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: 3 months ]
    according to RECIST criteria (CR + PR + SD)

  2. Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) [ Time Frame: 6 weeks ]
    according to the Peritoneal Regression Grading Score (PRGS)

  3. Safety according to CTCAE 4.0 [ Time Frame: 6 weeks ]
    according to CTCAE 4.0

  4. Quality of life according to QLQ-30 of EORTC [ Time Frame: 6-18 weeks ]
    according to QLQ-30 of EORTC

Biospecimen Retention:   Samples With DNA
Peritoneal samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In the rule, pretreated patients with chemoresistant peritoneal metastasis of various origins.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03210298

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Contact: Sabine Rhode +49 391 67 17960

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Roffo Cancer Institute Recruiting
Buenos Aires, Argentina
Contact: Laura Lay, MD   
Peter MacCallum Cancer Centre Recruiting
Melbourne, Australia
Contact: Craig Lynch, MD         
SALK - Salzburger Landeskliniken Recruiting
Salzburg, Austria
Contact: Tarkan Jäger, MD         
University Hospital Gent (UZ Gent) Recruiting
Gent, Belgium, 9000
Contact: Woulter Willaert, MD   
University Hospital Odense Recruiting
Odense, Denmark
Contact: Martin Graversen, MD   
Centre Hospitalier Universitaire Recruiting
Grenoble, France
Contact: Catherine Arvieux, MD   
Centre Hospitalier Universitaire Recruiting
Lille, France
Contact: Clarisse Eveno   
Hospices civils de Lyon Recruiting
Lyon, France
Contact: Olivier Glehen, MD    +33 478862371      
Centre du Cancer Recruiting
Montpellier, France
Contact: Olivia Sgarbura, MD   
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Verena Schlaich    +4970712986722   
IRCC Torino Candiolo Recruiting
Turin, Italy
Contact: Marco Vaira, MD   
F. Łukaszczyk Oncology Centre Recruiting
Bydgoszcz, Poland
Contact: Maciej Nowacki, MD   
Russian Federation
Gersten Institute for Cancer Research Recruiting
Moscow, Russian Federation
Contact: Vladimir Khomyakov, MD   
National University Hospital Recruiting
Singapore, Singapore
Contact: Janelle Phua   
Hospital de Pilar Recruiting
Barcelona, Spain
Contact: Juan Torrent, MD   
University Hospital Lausanne CHUV Recruiting
Lausanne, Switzerland, 1011
Contact: Martin Huebner, MD   
Sponsors and Collaborators
Sabine Rhode
Ruhr University of Bochum
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Principal Investigator: Philipp Horvath, MD University Hospital Tuebingen
Additional Information:


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sabine Rhode, Coordinator, University of Magdeburg Identifier: NCT03210298    
Other Study ID Numbers: RUB 15-5280
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: until 2021/12/31
Access Criteria: Approval through the independent scientific advisory board of the Institut for Quality Control, see above

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sabine Rhode, University of Magdeburg:
Pressurized IntraPeritoneal Aerosol Chemotherapy
Pressurized IntraThoracic Aerosol Chemotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Gallbladder Neoplasms
Appendiceal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Biliary Tract Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Cecal Neoplasms
Pseudomyxoma Peritonei
Pleural Effusion
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Pleural Diseases
Pathologic Processes
Pancreatic Diseases
Biliary Tract Diseases
Gallbladder Diseases