Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

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

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Switzerland
  • Zürich
    • Winterthur, Zürich, Switzerland, 8401
      • Recruiting
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with peritoneal carcinomatosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CRS and intraoperative chemotherapy; Patients receiving cytoreductive surgery and intraoperative chemotherapy (HIPEC/PIPAC)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: Carcinomatosis studyWinterthur

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No