Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
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ClinicalTrials.gov Identifier: NCT01709487 |
Recruitment Status
:
Completed
First Posted
: October 18, 2012
Last Update Posted
: February 24, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma | Procedure: HIPEC | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: HIPEC surgery with chemotherapy
|
Procedure: HIPEC
HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
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- mortality rate [ Time Frame: 24 weeks ]We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.
- progression free survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- stage III or only pleural stage IV ovarian carcinoma first line treatment
Exclusion Criteria:
- incomplete surgery poor performance status bad general condition

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709487
Belgium | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Hopital de la Citadelle | |
Liège, Belgium, 4000 |
Principal Investigator: | Joseph Kerger, M.D. | Institut Jules Bordet, Brussels, Belgium. | |
Principal Investigator: | Frédéric Goffin, M.D. | Hopital de la Citadelle, Liège, Belgium. |
Responsible Party: | Jules Bordet Institute |
ClinicalTrials.gov Identifier: | NCT01709487 History of Changes |
Other Study ID Numbers: |
HIPEC |
First Posted: | October 18, 2012 Key Record Dates |
Last Update Posted: | February 24, 2016 |
Last Verified: | July 2014 |
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 |