Rutten et al. BMC Cancer 2012, 12:31 http://www.biomedcentral.com/1471-2407/12/31 Patients with advanced ovarian cancer planned for PDS will be randomized to PDS or an additional diagnostic laparoscopy followed by either PDS or NACT and IDS. The rate of futile PDS in both groups (Figure 1) will be compared. A debulking surgery is regarded futile when the diameter of the largest residual tumour deposition is larger than 1 cm in diameter. The study is conducted according to the principles of the Declaration of Hel- sinki and in accordance with the Medical Research Involving Human Subjects Act (WMO) and has been approved by the ethics committee of the Academic Medical Centre Amsterdam (ref. no MEC 10/183). The protocol is registered in the Netherlands trial register number NTR 2644 Women suspected of ovarian cancer Conventional staging Primary debulking surgery feasible Randomization No laparoscopy Laparoscopy Debulking surgery feasible Debulking surgery not feasible Primary debulking Primary debulking Neoadjuvante chemotherapy fPurtiilemlaaprayrootoumtcyo#me: Secondary outcome: frequency of complete cytoreductive surgery, survival, quality of life, days in hospital, morbidity and costs Figure 1 LapOvCa-trial design. * = Physical examination, ultrasound, tumor markers, chest X-ray, abdominal CT. # = Largest residual tumor localization, left behind at the end of cytoreductive surgery, is more than 1 cm in diameter. Debulking surgery feasible: residual tumor after surgery will be < 1 cm. Debulking surgery not feasible: residual tumor after surgery will be > 1 cm. Page 3 of 6 Eligibility criteria Inclusion criteria patients Patients with advanced ovarian cancer who are planned for primary debulking surgery are eligible for this study. Patients have to be able to give written informed con- sent and aged between 18 and 80 years. Exclusion criteria patients Contraindications for PDS are exclusion criteria for this study. These include a WHO performance status of ≥ 3 and a large immobile pelvic tumour giving the impres- sion that complete debulking is not feasible. Further exclusion criteria are imaging techniques suggestive of intrahepatic metastatic disease of > one centimetre, extra-abdominal metastatic disease (excl inguinal lymph nodes or pleural fluid), peri-aortic lymphadenopathy lar- ger than one centimetre above the level of the renal veins, extensive peritoneal carcinomatosis at the level of the diaphragm giving the impression that surgery leav- ing no macroscopic tumour residual is impossible and extensive bowel mesentery involvement. Patient recruitment, randomization and collection of data Eligible patients are identified and counseled by the gynaecological staff of participating hospitals. Patients suspected of having advanced ovarian cancer are usually referred to a general gynaecologist. According to the national guideline for ovarian cancer, appropriate treat- ment as well as timing and localization of surgery will be discussed with a gynaecological oncologist from a centre hospital. All patients will undergo conventional staging, consisting of medical history, complete physical and gynaecological examination, ultrasound examina- tion, assessment of CA 125 and CEA serum levels, chest X-ray and contrast enhanced abdominopelvic CT. CT scanning will be performed using the standard equip- ment in the hospital in which the patients will undergo laparoscopy. All CT’s will be evaluated by an experi- enced radiologist and will be reviewed by the centre radiologist. The decision that a patient is eligible for PDS will be made by the gynaecological oncologist in collaboration with the referring gynaecologist on the basis of all avail- able information. All patients considered to be optimally operable will be offered PDS and will be asked to parti- cipate in this study. After written informed consent has been obtained, randomization will take place. Randomization is performed by accessing a central internet-based randomization program and is stratified by gynaecologic-oncologic centre hospital. Patients will be randomly allocated in a 1:1 ratio to two groups. The first group will undergo PDS followed by chemotherapy and the second group will undergo an additional diag- nostic laparoscopy. At study entry baseline demographic characteristics, medical history and findings of