title: Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study.
abstract: BACKGROUND
  Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer.
  
  
  METHODS
  Multicentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDS's leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat.
  
  
  CONCLUSIONS
  Patients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence of strong evidence and despite the possible complications, laparoscopy is already implemented in many countries. We propose a randomized multicentre trial to provide evidence on the effectiveness of laparoscopy before primary surgery for advanced stage ovarian cancer patients.
  
  
  BACKGROUND
  Netherlands Trial Register number NTR2644.
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands. m.j.rutten@amc.uva.nl
authors.forename: Marianne J
authors.initials: MJ
authors.lastname: Rutten
authors.forename: Katja N
authors.initials: KN
authors.lastname: Gaarenstroom
authors.forename: Toon
authors.initials: T
authors.lastname: Van Gorp
authors.forename: Hannah S
authors.initials: HS
authors.lastname: van Meurs
authors.forename: Henriette Jg
authors.initials: HJ
authors.lastname: Arts
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Bossuyt
authors.forename: Henk G
authors.initials: HG
authors.lastname: Ter Brugge
authors.forename: Ralph Hm
authors.initials: RH
authors.lastname: Hermans
authors.forename: Brent C
authors.initials: BC
authors.lastname: Opmeer
authors.forename: Johanna Ma
authors.initials: JM
authors.lastname: Pijnenborg
authors.forename: Henk Wr
authors.initials: HW
authors.lastname: Schreuder
authors.forename: Eltjo Mj
authors.initials: EM
authors.lastname: Schutter
authors.forename: Anje M
authors.initials: AM
authors.lastname: Spijkerboer
authors.forename: Celesta Wm
authors.initials: CW
authors.lastname: Wensveen
authors.forename: Petra
authors.initials: P
authors.lastname: Zusterzeel
authors.forename: Ben Willem J
authors.initials: BW
authors.lastname: Mol
authors.forename: Gemma G
authors.initials: GG
authors.lastname: Kenter
authors.forename: Marrije R
authors.initials: MR
authors.lastname: Buist
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008875:Middle Aged; D018365:Neoplasm, Residual; D009426:Netherlands; D010051:Ovarian Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis; D055815:Young Adult