Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)

Peritoneal Carcinomatosis Clinical Trial

— PIPAC_01  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100708
• Other study ID #: PIPAC_01
• Status: Recruiting
• Start date: April 2016
• Est. completion date: April 2021

Study information

• Verified date: September 2019
• Source: University of Leipzig
• Contact: Ines Gockel, Prof. Dr.
• Phone: +49 341 97 17200
• Email: ines.gockel[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Procedure:
• PIPAC
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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig - AöR	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (years)		5 years
Secondary	The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments		25 weeks
Secondary	Overall Response Rate (CT RESIST criteria)	Complete response	5 years
Secondary	Quality of lfe questionnaire (EORTC QLQ-C15-PAL)	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	5 years