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Completed

NCT Number: NCT01709487

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

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

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Key information

Conditions

Ovarian Carcinoma Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Carcinoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hopital de la Citadelle, Liège, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • incomplete surgery poor performance status bad general condition

Treatment and study plan

HIPEC

Procedure

HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. progression free survival

    Time frame: 3 years

  2. Overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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