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

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ClinicalTrials.gov Identifier: NCT03210298
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
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 (http://www.dgav.de/studoq/studoqhipec.html).


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 : May 2018
Estimated Study Completion Date : May 2019



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 ]
    Kaplan-Meier


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


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03210298


Contacts
Contact: Sabine Rhode +49 391 67 17960 sabine.rhode@med.ovgu.de

Locations
Argentina
Roffo Cancer Institute Recruiting
Buenos Aires, Argentina
Contact: Laura Lay, MD       lauralay@ymail.com   
Australia
Peter MacCallum Cancer Centre Recruiting
Melbourne, Australia
Contact: Craig Lynch, MD         
Belgium
University Hospital Gent (UZ Gent) Recruiting
Gent, Belgium, 9000
Contact: Woulter Willaert, MD       wouter.willaert@ugent.be   
Denmark
University Hospital Odense Recruiting
Odense, Denmark
Contact: Martin Graversen, MD       martin.graversen@rsyd.dk   
France
Hospices civils de Lyon Recruiting
Lyon, France
Contact: Olivier Glehen, MD    +33 478862371      
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Clarisse Eveno, MD    +33 1 49 95 25 80      
Germany
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Verena Schlaich    +4970712986722    pipac@med.uni-tuebingen.de   
India
Fortis Hospital Recruiting
Bengaluru, India
Contact: Aditi Bhatt, MD         
Italy
IRCC Torino Candiolo Recruiting
Turin, Italy
Contact: Marco Vaira, MD       marco.vaira@ircc.it   
Poland
F. Łukaszczyk Oncology Centre Recruiting
Bydgoszcz, Poland
Contact: Maciej Nowacki, MD       maciej.s.nowacki@gmail.com   
Russian Federation
Gersten Institute for Cancer Research Recruiting
Moscow, Russian Federation
Contact: Vladimir Khomyakov, MD       vladimirkhom@mail.ru   
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Janelle Phua       niam_sin_phua@nuhs.edu.sg   
Spain
Hospital de Pilar Recruiting
Barcelona, Spain
Contact: Juan Torrent, MD       juanjotorrent@yahoo.es   
Switzerland
University Hospital Lausanne CHUV Recruiting
Lausanne, Switzerland, 1011
Contact: Martin Huebner, MD       chv.carcinose@chuv.ch   
Sponsors and Collaborators
Sabine Rhode
Ruhr University of Bochum
Investigators
Principal Investigator: Cedric Demtroeder, MD Ruhr-University Bochum

Publications:

Responsible Party: Sabine Rhode, Coordinator, University of Magdeburg
ClinicalTrials.gov Identifier: NCT03210298     History of Changes
Other Study ID Numbers: RUB 15-5280
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
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

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
PIPAC
Pressurized IntraThoracic Aerosol Chemotherapy
PITAC
Cisplatin
Oxaliplatin
Gemcitabine
Paclitaxel
nab-Paclitaxel
Doxorubicine
Mitomycin

Additional relevant MeSH terms:
Pseudomyxoma Peritonei
Colorectal Neoplasms
Stomach Neoplasms
Mesothelioma
Pleural Effusion
Ascites
Gallbladder Neoplasms
Pancreatic Neoplasms
Appendiceal Neoplasms
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Diseases
Respiratory Tract Diseases
Pathologic Processes
Biliary Tract Neoplasms
Biliary Tract Diseases