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Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03124394
Enrollment
100
Registered
2017-04-21
Start date
2015-06-01
Completion date
2020-12-31
Last updated
2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Carcinomatosis

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.

Interventions

None listed

Sponsors

Kantonsspital Winterthur KSW
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative surgical complications90 daysReporting and grading of postoperative surgical complications (according to Dindo)
Rehospitalisation90 daysRehospitalisation: (yes/no), time frame, cause of rehospitalisation
Disease-free survival5 yearsTime to recurrence measured since diagnosis/Intervention (in months)
Overall Survival5 yearsAll cause mortality since diagnosis/Intervention (in months)

Secondary

MeasureTime frameDescription
Measurement of quality of life5 yearsValidated 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).
Cost-effectiveness90 daysAggregation of costs, charges, and revenues for the whole series and comparison with alternative treatment option as clinically relevant, chemotherapy alone and palliative surgery alone.
Cost90 daysAt the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs
Revenues90 daysAt the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index
Cost-utility analysis90 daysCalculation 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

Countries

Switzerland

Contacts

Primary ContactMichel Adamina, Prof/MD/MSc
Michel.Adamina@ksw.ch+41522663634
Backup ContactKantonsspital Winterthur

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026