Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer

Summary

Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin), fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ colorectal cancer. Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study. Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea, diarrhea vomiting over the 12 weeks. Safety will be evaluated including vital signs are recorded at all visits.

Timeline

Start

2012-10

Primary completion

2014-08

Completion

2014-09

Drugs

Indications