Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: NDP(80mg/m2) and DOC(60mg/m2) combination chemotherapy DOC (70mg/m2) chemotherapy CONDITION: Advanced or recurrent esophageal cancer PRIMARY OUTCOME: Overall survival SECONDARY OUTCOME: overall survival, one year survival rate, progression free survival, objective response rate, adverse events INCLUSION CRITERIA: 1.recurreent esophageal cancer 2.the tumor has a measurable lesion for evaluation. 3.5FU/CDDP resistance 4.ECOG PS:0 to 2 5.Age from 20 to 80 years 6.Adequate organ function WBC:>3,000/ mm3 <12,000/mm3 Neutro:>1,500/mm3 Hb:>9.0 g/dl Plt:>100,000/mm3 T‐Bil:<1.5mg / dl AST(GOT),ALT(GPT):within 2.5 times the normal upper limits Ccr: 1.5mg/dl C.Cr:>50ml / min (Cockcroft‐ Gault) 7. Written informed consent
Epistemonikos ID: e908dbb99c32c18c8dec248855433598aa007db7
First added on: Aug 22, 2024