Criticalities in randomized controlled trials on HIPEC for ovarian cancer

Table 1 Studies included in the review

Protocol no. (Name)	Country	Time point	Sample size	Randomization	Treatments	Primary outcome	Secondary outcome
NCT01091636	South Korea	Primary, recurrent OC	168	After surgery residual disease < 1 cm	CRS ± HIPEC with platinum 75 mg/m2 at 41.5 °C for 90 min	Progression free survival	Overall survival, quality of life
NCT00426257	The Netherlands	Secondary debulking surgery	280	ND	CRS ± HIPEC with platinum 100 mg/m2	Recurrence free survival	Toxicity, morbidity, quality of life, tumor response and overall survival
NCT01628380 (CHORINE study)	Italy	Primary advanced OC after NACT	94	After surgery residual disease < 2.5 mm	CRS ± HIPEC with platinum 100 mg/m2 + taxol 175 mg/m2, at 42 °C for 90 min, open or closed technique	Disease free survival	Morbidity, mortality, time to chemotherapy beginning after surgery, overall survival, 1, 3, 5-yr disease free survival and 1, 3, 5-yr overall survival
NCT01376752 (CHIPOR study)	France	Recurrent OC	444	After surgery residual disease < 2.5 mm	CRS ± HIPEC platinum 75 mg/m2	Overall survival	Relapse free survival
NCT01539785 (HORSE study)	Italy	Recurrent OC	158	ND	CRS ± HIPEC platinum 75 mg/m2) at 41.5 °C for 60 min, closed technique	Progression free interval	Overall survival, morbidity and mortality

OC: Ovarian cancer; NACT: Neoadjuvant chemotherapy; HIPEC: Hyperthermic intraperitoneal chemotherapy; CRS: Cytoreductive surgery; ND: Not declared.