NCT03124394

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

5.6 years

First QC Date

April 6, 2017

Last Update Submit

July 19, 2018

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Measurement of quality of life

    5 years

  • Cost

    90 days

  • Revenues

    90 days

  • Cost-utility analysis

    90 days

  • Cost-effectiveness

    90 days

Study Arms (1)

CRS and intraoperative chemotherapy

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with peritoneal carcinomatosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Study Officials

  • Michel Adamina, Prof/MD/MSc

    Kantonsspital Winterthur KSW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Adamina, Prof/MD/MSc

CONTACT

+41522663634Michel.Adamina@ksw.ch

Kantonsspital Winterthur

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 21, 2017

Study Start

June 1, 2015

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

CH(1)