A Phase II Trial Evaluating Efficacy and Safety of OpatinĀ® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with
recurrent or metastatic head and neck cancer.
To assess the safety profile of these treatment regimen. To evaluate the duration of
response of oxaliplatin/5-FU.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer
every 12 weeks
No
Chang Yi Fan, M.D.
Principal Investigator
Taipei Mackay Memorial Hospital
Taiwan : Food and Drug Administration
10CT006A
NCT01370876
September 2010
May 2012
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