title: Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Radboud University Medical Centre, PO Box 9101, 6500, HB, Nijmegen, The Netherlands. r.vandelaar@obgyn.umcn.nl.
authors.forename: Rafli
authors.initials: R
authors.lastname: van de Laar
authors.forename: Petra L M
authors.initials: PL
authors.lastname: Zusterzeel
authors.forename: Toon
authors.initials: T
authors.lastname: Van Gorp
authors.forename: Marrije R
authors.initials: MR
authors.lastname: Buist
authors.forename: Willemien J
authors.initials: WJ
authors.lastname: van Driel
authors.forename: Katja N
authors.initials: KN
authors.lastname: Gaarenstroom
authors.forename: Henriette J G
authors.initials: HJ
authors.lastname: Arts
authors.forename: Johannes C M
authors.initials: JC
authors.lastname: van Huisseling
authors.forename: Ralph H M
authors.initials: RH
authors.lastname: Hermans
authors.forename: Johanna M A
authors.initials: JM
authors.lastname: Pijnenborg
authors.forename: Eltjo M J
authors.initials: EM
authors.lastname: Schutter
authors.forename: Harold M P
authors.initials: HM
authors.lastname: Pelikan
authors.forename: Jos H A
authors.initials: JH
authors.lastname: Vollebergh
authors.forename: Mirjam J A
authors.initials: MJ
authors.lastname: Engelen
authors.forename: Joanna
authors.initials: J
authors.lastname: Inthout
authors.forename: Roy F P M
authors.initials: RF
authors.lastname: Kruitwagen
authors.forename: Leon F A G
authors.initials: LF
authors.lastname: Massuger
mesh_terms: D061605:Administration, Intravenous; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000077216:Carcinoma, Ovarian Epithelial; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D009426:Netherlands; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D010052:Ovariectomy / Q000009:adverse effects / Q000401:mortality; D017671:Platinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017671:Platinum Compounds