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

October 7, 2019 updated by: Sabine Rhode

Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In the rule, pretreated patients with chemoresistant peritoneal metastasis of various origins.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 to 5 years
Kaplan-Meier
1 to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Rate
Time Frame: 3 months
according to RECIST criteria (CR + PR + SD)
3 months
Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS)
Time Frame: 6 weeks
according to the Peritoneal Regression Grading Score (PRGS)
6 weeks
Safety according to CTCAE 4.0
Time Frame: 6 weeks
according to CTCAE 4.0
6 weeks
Quality of life according to QLQ-30 of EORTC
Time Frame: 6-18 weeks
according to QLQ-30 of EORTC
6-18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sabine Rhode

Collaborators

Ruhr University of Bochum

Investigators

  • Principal Investigator: Philipp Horvath, MD, University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUB 15-5280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Time Frame

until 2021/12/31

IPD Sharing Access Criteria

Approval through the independent scientific advisory board of the Institut for Quality Control, see above

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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