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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2014 by Jules Bordet Institute

Sponsor:

Information provided by (Responsible Party):

Jules Bordet Institute

ClinicalTrials.gov Identifier:

NCT01709487

First received: October 12, 2012

Last updated: July 14, 2014

Last verified: July 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma	Procedure: HIPEC	Phase 1 Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Fallopian Tube Cancer Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:

mortality rate [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.

Secondary Outcome Measures:

progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	24
Study Start Date:	May 2010
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HIPEC surgery with chemotherapy 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks Debulking surgery HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks	Procedure: HIPEC HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

incomplete surgery poor performance status bad general condition

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709487

Locations


Belgium
Institut Jules Bordet	Recruiting
Brussels, Belgium, 1000
Contact: Joseph Kerger, M.D. +3225413262 joseph.kerger@bordet.be
Contact: Lionel Cordier +3225413213 lionel.cordier@bordet.be
Principal Investigator: Joseph Kerger, M.D.
Hopital de la Citadelle	Recruiting
Liège, Belgium, 4000
Contact: Frédéric Goffin, M.D. +3242257543 fgoffin@chu.ulg.ac.be
Principal Investigator: Frédéric Goffin, M.D.

Sponsors and Collaborators

Jules Bordet Institute

Investigators


Principal Investigator:	Joseph Kerger, M.D.	Institut Jules Bordet, Brussels, Belgium.
Principal Investigator:	Frédéric Goffin, M.D.	Hopital de la Citadelle, Liège, Belgium.

More Information

No publications provided


Responsible Party:	Jules Bordet Institute
ClinicalTrials.gov Identifier:	NCT01709487 History of Changes
Other Study ID Numbers:	HIPEC
Study First Received:	October 12, 2012
Last Updated:	July 14, 2014
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Jules Bordet Institute:


HIPEC ovarian carcinoma Bordet

Additional relevant MeSH terms:


Carcinoma Neoplasms, Glandular and Epithelial Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases, Female	Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Ovarian Diseases Urogenital Neoplasms

ClinicalTrials.gov processed this record on March 03, 2015

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