This is a phase III, multicenter, interventional and randomized study which evaluates the use
of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking
Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This
study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC
combined with standard care (PDS or IDS) or standard care alone.
The primary objective of this study is to assess the efficacy, in terms of disease-free
survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or
standard care alone (PDS or IDS alone).
Secondary objectives of the study include:
Evaluating the efficacy of HIPEC in terms of overall survival (OS) in combination with
standard of care
Evaluating the morbidity associated with HIPEC.
Evaluating the trade-off between efficacy and morbidity using the Q-TWiST approach.
Evaluating the impact of HIPEC in terms of quality of life.
Exploratory objectives (optional) include:
Evaluating the impact of HIPEC on the count of residual viable cells (evaluated by flow
cytometry) in abdominal drainage fluids for patients recruited in Centre Oscar Lambret
Constituting a biobank (tumoral samples and blood samples) for future translational
Epithelial Ovarian Carcinoma,
Recurrent Ovarian Cancer,
ovarian epithelial carcinoma,
carcinoma of the ovary,
cancer of the ovary,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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