Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Primary Peritoneal Carcinoma Clinical Trial

Official title:

Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709487
• Other study ID #: HIPEC
• 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

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

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