Ovarian Epithelial Cancer Clinical Trial
Official title:
Assessment of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer
With 4,600 new cases in France in 2012, ovarian cancer is the seventh most common cancer in
women and the fourth cause of mortality by cancer. Despite a high response rate to initial
treatment, most patients will relapse within 2 years. No standard treatment has yet been
established for patients with recurrent ovarian cancer.
Most patients with such recurrences are currently treated with new combinations of systemic
chemotherapy. A repeated laparotomy with complete cytoreduction is also an option that
several authors have used to obtain median survival rates of more than 30 months.
Twenty five percent of patients experiencing relapse present with platinum-resistant
recurrence, occurring less than 6 months after chemotherapy completion. Recently, Pujade et
al. showed that adding bevacizumab to chemotherapy significantly improves progression-free
survival (PFS) in this subgroup of patients with poor prognoses (16.6 months versus 13.3
months in women treated with chemotherapy alone). Three case control studies have compared
systemic chemotherapy and CRS (Cytoreduction Surgery) alone versus CRS plus HIPEC in patients
with recurrent disease. They showed significantly improved results with the addition of
HIPEC. In the French registry that included 474 patients with recurrence and peritoneal
carcinomatosis, the median PFS was 13.8 months for platinum-resistant patients and 13 months
for platinum-sensitive patients. Our hypothesis is that surgery would reduce the tumor burden
and consequently the number of platinum-resistant tumor clones and that HIPEC would control
the microscopic residual disease by increasing the tumor cell cytotoxicity.
We assume that adding a locoregional treatment to an "Aurelia-like" systemic treatment would
improve the PFS. We aim to assess the benefit of adding surgery and HIPEC to the treatment of
first or second platinum-resistant recurrence compared to chemotherapy + bevacizumab.
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