Ovarian Cancer Clinical Trial
Official title:
Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)
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 only. - Constituting a biobank (tumoral samples and blood samples) for future translational researches ;
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