Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)
PIPAC_01
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.
1 other identifier
observational
500
1 country
1
Brief Summary
The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedSeptember 25, 2019
September 1, 2019
5 years
November 15, 2016
September 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (years)
5 years
Secondary Outcomes (3)
The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments
25 weeks
Overall Response Rate (CT RESIST criteria)
5 years
Quality of lfe questionnaire (EORTC QLQ-C15-PAL)
5 years
Study Arms (1)
Patient with peritoneal carcinomatosis
Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed.
Interventions
* Cisplatin 7.5 mg/m2 body surface in 150 ml NaCl 0,9% + Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% in patients with ovarian, gastric, pancreatic cancer and in primary peritoneal tumors. * Oxaliplatin 92 mg/m2 body surface in 150 ml dextrose solution in patients with colorectal cancer. 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.
Eligibility Criteria
Patients suffer from peritoneal carcinomatosis.
You may qualify if:
- Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors
- Age \> 18 years
- signed informed consent
You may not qualify if:
- Patient can not understand meaning and purpose of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103, Germany
Related Publications (3)
Jansen-Winkeln B, Eberth J, Moulla Y, Mehdorn M, Niebisch S, Schierle K, Blaker H, Lordick F, Gockel I, Thieme R. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal surface malignancies (PSM): a prospective single-center registry study. J Cancer Res Clin Oncol. 2023 Mar;149(3):1331-1341. doi: 10.1007/s00432-022-04517-w. Epub 2022 Dec 13.
PMID: 36513815DERIVEDGockel I, Jansen-Winkeln B, Haase L, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer. Tumori. 2020 Feb;106(1):70-78. doi: 10.1177/0300891619868013. Epub 2019 Aug 30.
PMID: 31469058DERIVEDGockel I, Jansen-Winkeln B, Haase L, Rhode P, Mehdorn M, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Cancer Patients with Peritoneal Metastasis (PM): Results of a Single-Center Experience and Register Study. J Gastric Cancer. 2018 Dec;18(4):379-391. doi: 10.5230/jgc.2018.18.e37. Epub 2018 Dec 14.
PMID: 30607301DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ines Gockel, Prof. Dr.
Universitätsklinikum Leipzig
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. B. Jansen-Winkeln and Prof. Dr. I. Gockel
Study Record Dates
First Submitted
November 15, 2016
First Posted
April 4, 2017
Study Start
April 1, 2016
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
September 25, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share