Clinical trial NCT03100708: Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Carcinomatosis
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffer from peritoneal carcinomatosis.

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).


Eligibility criteria: Inclusion Criteria:

* Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors
* Age \> 18 years
* signed informed consent

Exclusion Criteria:

* Patient can not understand meaning and purpose of the study

Primary outcomes:
measure: Overall Survival (years)
timeFrame: 5 years
Secondary outcomes:
measure: The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments
timeFrame: 25 weeks
measure: Overall Response Rate (CT RESIST criteria)
timeFrame: 5 years
measure: Quality of lfe questionnaire (EORTC QLQ-C15-PAL)
timeFrame: 5 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - AöR
state: Sachsen
Study officials:
affiliation: Universitätsklinikum Leipzig
name: Ines Gockel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gockel 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.
citation: Gockel 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.