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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01709487
Other study ID # HIPEC
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 12, 2012
Last updated February 23, 2016
Start date May 2010
Est. completion date October 2015

Study information

Verified date July 2014
Source Jules Bordet Institute
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.


Description:

Addition of HIPEC to the standard first line treatment of ovarian carcinoma.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion Criteria:

- incomplete surgery poor performance status bad general condition

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
HIPEC
HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

Locations

Country Name City State
Belgium Institut Jules Bordet Brussels
Belgium Hopital de la Citadelle Liège

Sponsors (1)

Lead Sponsor Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary mortality rate We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy. 24 weeks Yes
Secondary progression free survival 3 years No
Secondary Overall survival 3 years No
See also
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