Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) (PIPAC_01)
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|ClinicalTrials.gov Identifier: NCT03100708|
Recruitment Status : Unknown
Verified September 2019 by Dr. Boris Jansen-Winkeln, University of Leipzig.
Recruitment status was: Recruiting
First Posted : April 4, 2017
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment|
|Peritoneal Carcinomatosis||Procedure: PIPAC|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Evaluation of Molecular and Pathophysiological Mechanisms of Peritoneal Carcinomatosis and Monitoring of the Efficiency of PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) as a Local Chemotherapeutical Treatment.|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Patient with peritoneal carcinomatosis
Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed.
The chemotherapeutics will be admitted to the abdomen by a nebulizer at a pressure of 200 psi and 12 mmHG with 0.5 mL/sec. Afterwards the chemotherapeutics can react for 30min before the abdominal gas will be drained to the clinics filtering system.
Other Name: Pressurized Intra-peritoneal Aerosol-Chemotherapy
- Overall Survival (years) [ Time Frame: 5 years ]
- The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments [ Time Frame: 25 weeks ]
- Overall Response Rate (CT RESIST criteria) [ Time Frame: 5 years ]Complete response
- Quality of lfe questionnaire (EORTC QLQ-C15-PAL) [ Time Frame: 5 years ]Groenvold M et al. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. European Journal of Cancer 2006; 42(1): 55-64
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): NCT03100708
|Contact: Ines Gockel, Prof. Dr.||+49 341 97 email@example.com|
|Contact: Boris Jansen-Winkeln, Dr.||+49 341 97 firstname.lastname@example.org|
|Universitätsklinikum Leipzig - AöR||Recruiting|
|Leipzig, Sachsen, Germany, 04103|
|Principal Investigator:||Ines Gockel, Prof. Dr.||Universitätsklinikum Leipzig|