Open Access Study protocol

Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study

Rafli van de Laar1*, Petra LM Zusterzeel1, Toon Van Gorp2, Marrije R Buist3, Willemien J van Driel4, Katja N Gaarenstroom5, Henriette JG Arts6, Johannes CM van Huisseling7, Ralph HM Hermans8, Johanna MA Pijnenborg9, Eltjo MJ Schutter10, Harold MP Pelikan11, Jos HA Vollebergh12, Mirjam JA Engelen13, Joanna IntHout14, Roy FPM Kruitwagen2 and Leon FAG Massuger1

Author Affiliations

1 Department of Obstetrics and Gynecology, Radboud University Medical Centre, PO Box 9101, 6500, HB, Nijmegen, The Netherlands

2 Department of Obstetrics and Gynaecology, Maastricht University Medical Center, GROW -School for Oncology and Developmental Biology, Maastricht, The Netherlands

3 Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands

4 Department of Obstetrics and Gynaecology, Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

5 Department of Obstetrics and Gynaecology, Leiden University Medical Center, Leiden, The Netherlands

6 Department of Gynaecology, University Medical Center Groningen, Groningen, The Netherlands

7 Department of Obstetrics and Gynaecology, Groene Hart Hospital, Gouda, The Netherlands

8 Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands

9 Department of Obstetrics and Gynaecology, TweeSteden Hospital, Tilburg, The Netherlands

10 Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, The Netherlands

11 Department of Obstetrics and Gynaecology, Bronovo Hospital, Den Haag, The Netherlands

12 Department of Obstetrics and Gynaecology, Bernhoven Hospital, Uden, The Netherlands

13 Department of Obstetrics and Gynaecology, Atrium Medical Center, Heerlen, The Netherlands

14 Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands

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BMC Cancer 2014, 14:22  doi:10.1186/1471-2407-14-22

Published: 14 January 2014

Abstract

Background

Improvement 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/Design

Multicentre 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.

Discussion

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. 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 registration

Netherlands Trial Register number: NTR3337.

Keywords:
Secondary cytoreductive surgery; Recurrent; Platinum-sensitive; Ovarian cancer