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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

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Trial Information

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


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


Inclusion Criteria:



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

Exclusion Criteria:

- incomplete surgery poor performance status bad general condition

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

mortality rate

Outcome Description:

We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Joseph Kerger, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Jules Bordet, Brussels, Belgium.

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

HIPEC

NCT ID:

NCT01709487

Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • HIPEC
  • ovarian carcinoma
  • Bordet
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Fallopian Tube Neoplasms

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