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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jules Bordet Institute

ClinicalTrials.gov Identifier:

NCT01709487

First received: October 12, 2012

Last updated: February 23, 2016

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:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Ovarian Cancer

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


Enrollment:	19
Study Start Date:	May 2010
Study Completion Date:	October 2015
Primary Completion Date:	October 2015 (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 (Adult, Senior)
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
Brussels, Belgium, 1000
Hopital de la Citadelle
Liège, Belgium, 4000

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


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:	February 23, 2016
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 Ovarian Neoplasms Neoplasms, Glandular and Epithelial Fallopian Tube Neoplasms Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site	Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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