NCIC CTG OV.21.

Trial name or title	NCIC CTG OV.21
Methods	Study duration: Projected to take 4.5 years to complete accrual Type of trial: Multicentre RCT with collaborating institutions in Canada, UK, Spain and the USA No. ineligible: (to be determined)
Participants	Women with EOC and optimal tumour debulking after 3‐4 cycles of neoadjuvant chemotherapy Stage: IIb‐IIIa Residual disease status: ≤ 1 cm Performance status: ≤ 2 Number to be randomised: 150 (Phase II trial) and 630 (Phase III trial) Number evaluable: (to be determined)
Interventions	Arm 1: IV paclitaxel 135 mg/m² plus IV carboplatin on day 1; IV paclitaxel 60 mg/m² on day 8 Arm 2: IV paclitaxel 135 mg/m² plus IP carboplatin or cisplatin* on day 1; IP paclitaxel on day 8 Repeated every 21 days for 3 cycles
Outcomes	PFS, OS, toxic effects, QOL, cost/benefit and correlative biology studies
Starting date	2011
Contact information	Helen.Mackay@uhn.on.ca
Notes	Phase III trial to be preceded by a Phase II trial with three arms: IV only, cisplatin IP component therapy and carboplatin IP component therapy. 50 women will be recruited to each arm. *Arm 2 IP chemo agent to be determined by the outcome of the Phase II part of the trial