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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03210298




Registration number
NCT03210298
Ethics application status
Date submitted
29/06/2017
Date registered
6/07/2017

Titles & IDs
Public title
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)
Scientific title
Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases
Secondary ID [1] 0 0
RUB 15-5280
Universal Trial Number (UTN)
Trial acronym
PIPACRegis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneum Cancer 0 0
Peritoneum Neoplasm 0 0
Pleural Cancer 0 0
Pleural Effusion 0 0
Pleural Mesothelioma 0 0
Ovarian Cancer 0 0
Gastric Cancer 0 0
Appendix Cancer 0 0
Pseudomyxoma Peritonei 0 0
Colorectal Cancer 0 0
Pancreas Cancer 0 0
Gallbladder Cancer 0 0
Ascites 0 0
CUP 0 0
Chemotherapeutic Toxicity 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - PIPAC

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
1 to 5 years
Secondary outcome [1] 0 0
Clinical Benefit Rate
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS)
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Safety according to CTCAE 4.0
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Quality of life according to QLQ-30 of EORTC
Timepoint [4] 0 0
6-18 weeks

Eligibility
Key inclusion 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
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- bowel obstruction

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2022
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Denmark
State/province [4] 0 0
Odense
Country [5] 0 0
France
State/province [5] 0 0
Grenoble
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Montpellier
Country [9] 0 0
Germany
State/province [9] 0 0
Tübingen
Country [10] 0 0
Italy
State/province [10] 0 0
Turin
Country [11] 0 0
Poland
State/province [11] 0 0
Bydgoszcz
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Moscow
Country [13] 0 0
Singapore
State/province [13] 0 0
Singapore
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Switzerland
State/province [15] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Sabine Rhode
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ruhr University of Bochum
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philipp Horvath, MD
Address 0 0
University Hospital Tuebingen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabine Rhode
Address 0 0
Country 0 0
Phone 0 0
+49 391 67 17960
Fax 0 0
Email 0 0
sabine.rhode@med.ovgu.de
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
until 2021/12/31
Available to whom?
Approval through the independent scientific advisory board of the Institut for Quality Control, see above
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03210298