Peritoneal CarcinomatosisNCT03124394
Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study
An observational study of Peritoneal Carcinomatosis, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2015to 31 Dec 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peritoneal carcinomatosis
Who may be able to join
- Men and Women >18 years
- Tumour board decision for CRS and intraoperative chemotherapy
Who cannot join
- Missing Tumour board decision for CRS and intraoperative chemotherapy
- Pregnancy
- Age <18 years
Trial locations and contacts
1 site in 1 country.
Kantonsspital Winterthur contact
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Michel Adamina, Prof/MD/MSc, +41522663634, michel.adamina@ksw.ch
About this study
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.
- Conditions
- Peritoneal Carcinomatosis
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRS and intraoperative chemotherapy | Patients receiving cytoreductive surgery and intraoperative chemotherapy (HIPEC/PIPAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative surgical complications
Reporting and grading of postoperative surgical complications (according to Dindo)
Measured: 90 days
Rehospitalisation
Rehospitalisation: (yes/no), time frame, cause of rehospitalisation
Measured: 90 days
Disease-free survival
Time to recurrence measured since diagnosis/Intervention (in months)
Measured: 5 years
Overall Survival
All cause mortality since diagnosis/Intervention (in months)
Measured: 5 years
Secondary outcomes (5)
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).
Measured: 5 years
Cost
At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs
Measured: 90 days
Revenues
At the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index
Measured: 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
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jun 2015
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Adamina, Prof/MD/MSc, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124394
- Sponsor's protocol ID
- Carcinomatosis studyWinterthur
- Status last verified
- Jul 2018
- First submitted
- 6 Apr 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study
- ClinicalTrials.gov ID
- NCT03124394
- Acronym / sponsor ID
- Carcinomatosis studyWinterthur
- Conditions
- Peritoneal Carcinomatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRS and intraoperative chemotherapy | – | –Patients receiving cytoreductive surgery and intraoperative chemotherapy (HIPEC/PIPAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peritoneal carcinomatosis
Key inclusion criteria (2 listed)
- Men and Women >18 years
- Tumour board decision for CRS and intraoperative chemotherapy
Key exclusion criteria (3 listed)
- Missing Tumour board decision for CRS and intraoperative chemotherapy
- Pregnancy
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative surgical complications
Time frame: 90 days
Reporting and grading of postoperative surgical complications (according to Dindo)
Rehospitalisation
Time frame: 90 days
Rehospitalisation: (yes/no), time frame, cause of rehospitalisation
Disease-free survival
Time frame: 5 years
Time to recurrence measured since diagnosis/Intervention (in months)
Overall Survival
Time frame: 5 years
All cause mortality since diagnosis/Intervention (in months)
5 secondary outcomes
Measurement of quality of life
Time frame: 5 years
Cost
Time frame: 90 days
Revenues
Time frame: 90 days
Cost-utility analysis
Time frame: 90 days
Cost-effectiveness
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kantonsspital Winterthur contact
Michel Adamina, Prof/MD/MSc principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Carcinomatosis, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Adamina, Prof/MD/MSc (+41522663634, Michel.Adamina@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative surgical complications (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.