Open Access Study protocol

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

Marianne J Rutten1*, Katja N Gaarenstroom2, Toon Van Gorp3, Hannah S van Meurs1, Henriette JG Arts4, Patrick M Bossuyt5, Henk G Ter Brugge6, Ralph HM Hermans7, Brent C Opmeer8, Johanna MA Pijnenborg9, Henk WR Schreuder10, Eltjo MJ Schutter11, Anje M Spijkerboer12, Celesta WM Wensveen13, Petra Zusterzeel14, Ben Willem J Mol1, Gemma G Kenter1 and Marrije R Buist1

Author Affiliations

1 Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands

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

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

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

5 Department of Clinical Epidemiology Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands

6 Department of Obstetrics and Gynaecology, Isala Klinieken Zwolle, Zwolle, The Netherlands

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

8 Clinical Research Unit, Academic Medical Centre, Amsterdam, The Netherlands

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

10 Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands

11 Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, The Netherlands

12 Department of Radiology, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands

13 Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, The Netherlands

14 Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

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BMC Cancer 2012, 12:31  doi:10.1186/1471-2407-12-31

Published: 20 January 2012

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.

Discussion

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.

Trial registration

Netherlands Trial Register number NTR2644