A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)
It is considered realistic, that within 18 months 120 patients can be included in the
participating centers. Based on the previous publications an objective response rate (ORR)
of 20% is expected in the GEMOX arm (Arm B). When the sample size of evaluable patients is
between 110 and 120 evaluable patients (ie. 55 to 60 patients per treatment arm), then a
two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB,
of 20% and an arm A response rate PA of 30%, 35% or 40% based on the large sample normal
approximation will have a width between 15.4% and 16.7%. We assume an objective response
rate of 30% for Arm A, then a two-sided 95% confidence interval (CI) for the difference
between an arm B response rate PB, of 20% and an arm A response rate PA of 30% will have a
width ±15.4% when the sample size of evaluable patients is 120 (i.e., 60 patients per
treatment arm).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response rate
Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.
baseline and every 8 weeks
Yes
Li Tz Chen, PHD
Study Chair
National Institute of Cancer Research
Taiwan: Institutional Review Board
T1210
NCT01267344
December 2010
December 2013
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