Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

• Conditions: Peritoneal Carcinomatosis

• Registration Number: NCT03124394
• Lead Sponsor: Kantonsspital Winterthur KSW

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years	All cause mortality since diagnosis/Intervention (in months)
Postoperative surgical complications	90 days	Reporting and grading of postoperative surgical complications (according to Dindo)
Disease-free survival	5 years	Time to recurrence measured since diagnosis/Intervention (in months)
Rehospitalisation	90 days	Rehospitalisation: (yes/no), time frame, cause of rehospitalisation

Secondary Outcome Measures

Name	Time	Method
Cost	90 days	At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs
Measurement of quality of life	5 years	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).
Revenues	90 days	At the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index
Cost-effectiveness	90 days	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.
Cost-utility analysis	90 days	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

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zürich, Switzerland