Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Peritoneal Carcinomatosis Clinical Trial

Official title:

Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124394
• Other study ID #: Carcinomatosis studyWinterthur
• Status: Recruiting
• Start date: June 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Kantonsspital Winterthur KSW
• Contact: Michel Adamina, Prof/MD/MSc
• Phone: +41522663634
• Email: Michel.Adamina[@]ksw.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis.

Description:

Peritoneal carcinomatosis is a dooming finding with no hope for cure and a steadily decrease in quality of life. Cytoreductive surgery with intraperitoneal chemotherapy (CRS HIPEC) offers a small but proven chance for cure. The implementation of a CRS HIPEC and PIPAC programme in a Swiss tertiary care hospital is evaluated.

When a patient is deemed non resectable, pressurized intraperitoneal aerosol chemotherapy (PIPAC) administered laparoscopically may confer effective palliation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and Women >18 years

• Tumour board decision for CRS and intraoperative chemotherapy

Exclusion Criteria:

• Missing Tumour board decision for CRS and intraoperative chemotherapy

• Pregnancy

• Age <18 years

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative surgical complications	Reporting and grading of postoperative surgical complications (according to Dindo)	90 days
Primary	Rehospitalisation	Rehospitalisation: (yes/no), time frame, cause of rehospitalisation	90 days
Primary	Disease-free survival	Time to recurrence measured since diagnosis/Intervention (in months)	5 years
Primary	Overall Survival	All cause mortality since diagnosis/Intervention (in months)	5 years
Secondary	Measurement of quality of life	Validated measurements of health-related quality of life according to the EORTC manual in terms of general quality of life: EORTC-QLQ30; disease-specific quality of life: EORTC-CR29 (colorectal cancers), and health-utility (EQ-5D).	5 years
Secondary	Cost	At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs	90 days
Secondary	Revenues	At the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index	90 days
Secondary	Cost-utility analysis	Calculation and comparison of QUALY (quality-adjusted life years derived from EQ-5D) for competing treatment strategies taking advantage of published figures and own data, e.g. cost of a systemic palliative chemotherapy compared to cost of an intraperitoneal chemotherapy	90 days
Secondary	Cost-effectiveness	Aggregation of costs, charges, and revenues for the whole series and comparison with alternative treatment option as clinically relevant, chemotherapy alone and palliative surgery alone.	90 days