Kumar 2009.

Study name	Kumar
Methods	RCT; open‐label
Participants	180 women Included if: age 20 to 65 years; EOC stage IIIc & IV (pleural effusion only); ECOG PS 0‐2; cytology/biopsy‐positive women; good compliance; previously untreated women Excluded if: any medical contraindication to surgery; psychiatric illness; cardiac, liver or renal dysfunction
Interventions	Upfront surgery followed by 6 cycles of paclitaxel + carboplatin (chemotherapy) (arm A) or upfront chemotherapy ‐ 3 cycles chemotherapy followed by surgery then 3 more cycles of chemotherapy
Outcomes	Optimal debulking rate (≤ 1 cm), OS, PFS, clinical CR, QoL, operating time, blood loss, stay in ICU, duration of hospital stay, infections, chemo‐toxicity
Starting date
Contact information	lalitaiims@yahoo.com
Notes	Clinical Trials Register: NCT00715286 Interim results presented at 2007 ASCO meeting: 113/139 women evaluable, 20% optimally debulked in PDS group versus 85% in the NACT group. NACT group also experienced less blood loss (P = 0.01), shorter hospital stay (P = 0.04), less postoperative infection (2 cases versus 7 cases; P = 0.06) and less operative mortality (1 deaths versus 5 deaths; P = 0.08). Median OS was 29 months in PDS group versus 41 months in NACT group. Interim results presented in Kumar 2009: 128/133 women evaluable, 62 in PDS group, 66 in NACT group. Optimum debulking was achieved in 22.6% and 86.2% (P < 0.0001), respectively. The NACT group experienced less blood loss (413 mL versus 600 mL; P < 0.0001), reduced postoperative infections (1.54% versus 14.5%; P < 0.025), reduced operating time (75.4 minutes versus 89.2 minutes; P < 0.001) and shorter hospital stay (7.6 days versus 11.5 days; P < 0.001). Median follow‐up at 42 months found similar OS of 42 months and 41 months in the PDS and NACT group, respectively (the 2007 results presented showed significantly better OS in the NACT group). HR for OS (PDS versus NACT) was 0.94; 95% CI 0.56 to 1.56. HR for PFS (PDS versus NACT) was 1.1; 95% CI 0.71 to 1.86. QoL score was significantly better in the NACT group 'at the end of treatment' (P < 0.001) There are some discrepancies in these data when compared with the 2007 interim results (e.g. OS data). Furthermore, the denominators used to create these data were not stated in Kumar 2009, and continuous data were presented without standard deviations. The authors stated that complete results will be published soon.