International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) (PIPACRegis)
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ClinicalTrials.gov Identifier: NCT03210298 |
Recruitment Status : Unknown
Verified October 2019 by Sabine Rhode, University of Magdeburg.
Recruitment status was: Recruiting
First Posted : July 6, 2017
Last Update Posted : October 8, 2019
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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 |
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 : | September 2022 |
Estimated Study Completion Date : | September 2022 |
- 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
- Overall survival [ Time Frame: 1 to 5 years ]Kaplan-Meier
- Clinical Benefit Rate [ Time Frame: 3 months ]according to RECIST criteria (CR + PR + SD)
- Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) [ Time Frame: 6 weeks ]according to the Peritoneal Regression Grading Score (PRGS)
- Safety according to CTCAE 4.0 [ Time Frame: 6 weeks ]according to CTCAE 4.0
- 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
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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 |
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
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
Contact: Sabine Rhode | +49 391 67 17960 | sabine.rhode@med.ovgu.de |
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 | |
Austria | |
SALK - Salzburger Landeskliniken | Recruiting |
Salzburg, Austria | |
Contact: Tarkan Jäger, MD | |
Contact ta.jaeger@salk.at | |
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 | |
Centre Hospitalier Universitaire | Recruiting |
Grenoble, France | |
Contact: Catherine Arvieux, MD carvieux@chu-grenoble.fr | |
Centre Hospitalier Universitaire | Recruiting |
Lille, France | |
Contact: Clarisse Eveno clarisse.eveno@gmail.com | |
Hospices civils de Lyon | Recruiting |
Lyon, France | |
Contact: Olivier Glehen, MD +33 478862371 | |
Centre du Cancer | Recruiting |
Montpellier, France | |
Contact: Olivia Sgarbura, MD olivia.sgarbura@icm.unicancer.fr | |
Germany | |
University Hospital Tübingen | Recruiting |
Tübingen, Germany, 72076 | |
Contact: Verena Schlaich +4970712986722 pipac@med.uni-tuebingen.de | |
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 |
Principal Investigator: | Philipp Horvath, MD | University Hospital Tuebingen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sabine Rhode, Coordinator, University of Magdeburg |
ClinicalTrials.gov 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 |
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 |
Pressurized IntraPeritoneal Aerosol Chemotherapy PIPAC Pressurized IntraThoracic Aerosol Chemotherapy PITAC Cisplatin Oxaliplatin |
Gemcitabine Paclitaxel nab-Paclitaxel Doxorubicine Mitomycin |
Mesothelioma Pancreatic Neoplasms Gallbladder Neoplasms Pseudomyxoma Peritonei Appendiceal Neoplasms Pleural Effusion Ascites Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Endocrine Gland Neoplasms Endocrine System Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Respiratory Tract Diseases Pleural Diseases Pathologic Processes Pancreatic Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases Adenocarcinoma, Mucinous Adenocarcinoma |