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Status unknownNCT03124394Updated Jul 20, 2018

Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

An observational study in Peritoneal Carcinomatosis, sponsored by Kantonsspital Winterthur KSW. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-20.

Sponsored by Kantonsspital Winterthur KSW · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Peritoneal Carcinomatosis
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 100 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with peritoneal carcinomatosis

Inclusion criteria

  • Men and Women >18 years
  • Tumour board decision for CRS and intraoperative chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Missing Tumour board decision for CRS and intraoperative chemotherapy
  • Pregnancy
  • Age \<18 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • CRS and intraoperative chemotherapy

    Patients receiving cytoreductive surgery and intraoperative chemotherapy (HIPEC/PIPAC)

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What researchers measure

Primary outcomes

  1. Postoperative surgical complications

    Reporting and grading of postoperative surgical complications (according to Dindo)

    Time frame: 90 days

  2. Rehospitalisation

    Rehospitalisation: (yes/no), time frame, cause of rehospitalisation

    Time frame: 90 days

  3. Disease-free survival

    Time to recurrence measured since diagnosis/Intervention (in months)

    Time frame: 5 years

  4. Overall Survival

    All cause mortality since diagnosis/Intervention (in months)

    Time frame: 5 years

Secondary outcomes

  1. 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).

    Time frame: 5 years

  2. Cost

    At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs

    Time frame: 90 days

  3. Revenues

    At the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index

    Time frame: 90 days

  4. 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

    Time frame: 90 days

  5. 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.

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Kantonsspital Winterthur
    Winterthur, Zürich 8401, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03124394
Lead sponsor
Kantonsspital Winterthur KSW
Responsible party
Sponsor
First posted
Apr 21, 2017
Start date
Jun 1, 2015
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 20, 2018

Study contacts

Michel Adamina, Prof/MD/MSc
Contact
Michel.Adamina@ksw.ch
+41522663634
Kantonsspital Winterthur
Contact
Michel Adamina, Prof/MD/MSc
principal investigator · Kantonsspital Winterthur KSW

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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