Abstract
BackgroundImprovement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.Methods/DesignMulticentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.DiscussionWhere the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.Trial registrationNetherlands Trial Register number: NTR3337.
Highlights
Improvement in treatment for patients with recurrent ovarian cancer is needed
Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far
The 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed
Summary
Other clinical trials Currently, there are two other ongoing randomized controlled trials: the DESKTOP III trial (NCT01166737) and the GOG 213 trial (NCT00565851). The DESKTOP III trial will compare overall survival in patients with platinumsensitive recurrent ovarian cancer with a positive AGOscore randomized to cytoreductive surgery followed by chemotherapy of physician’s choice versus chemotherapy of physician’s choice alone whereas the GOG 213 trial will determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy comprising carboplatin and paclitaxel with or without bevacizumab increases the duration of overall survival of patients with recurrent platinumsensitive ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. A better understanding of the real advantages and disadvantages and patient’s selection criteria for secondary cytoreductive surgery will be achieved after the completion of these three ongoing trials
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