Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Study Overview
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Brief Summary
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Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis.

Detailed Description
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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.

Official Title
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Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Conditions
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Peritoneal Carcinomatosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRS and intraoperative chemotherapy<br>Patients receiving cytoreductive surgery and intraoperative chemotherapy (HIPEC/PIPAC) | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Cost | At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs | 90 days | 
| Revenues | At the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index | 90 days | 
| 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 | 
| 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 |