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

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.

Tracking Information
First Received DateJune 29, 2017
Last Changed DateJuly 10, 2017
Start DateJanuary 2016
Anticipated Primary Completion DateMay 2018
Primary Outcome Measures

Overall survival [Time Frame: 1 to 5 years]

Secondary Outcome Measures

Clinical Benefit Rate [Time Frame: 3 months]

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

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

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

Descriptive Information
PhaseN/A
Study TypeObservational [Patient Registry]
Condition
  • 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
Intervention
  • Combination Product: PIPAC
Study Arms / Comparison Groups0 / 1
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).

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment1000
GenderAll
Ages10 Years - N/A
Accepts Healthy VolunteersNo
Contact Sabine Rhode
Email: sabine.rhode@med.ovgu.de
Phone: +49 391 67 17960
Eligibility 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

Administrative Information
NCTIDNCT03210298
Responsible Party,
SponsorSabine Rhode
Verification DateJuly 2017
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