A Phase III Randomized Study of Phase III Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer
The patient received before the surgery a second line chemotherapy, platinum-based regimen
with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses
IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery
seems possible, the patient is included after signed informed consent and will be operated 5
to 8 weeks after the last second-line chemotherapy cycle.
So, during the surgery the patient will be randomized if the complete cytoreductive surgery
is really done and will then receive:
- either treatment A = maximal cytoreductive surgery without HIPEC
- or treatment B = maximal cytoreductive surgery with HIPEC
The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor
residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0
(no residual)-CC1 (residual < 0.25cm).
Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site
practice. Each site will use the same method during the study for all included patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
There is a follow-up period of 4 years.
from randomization to death (up to 4 years)
Centre rené Gauducheau, NANTES
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
FEDEGYN 02 / 0410-CHIPOR