The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
continuous chest radiation at 64 Gy/32f
Hui Liu
Guangzhou, Guangdong, China
Occurrence of dose limiting toxicity
Time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Maximum tolerated dose
Time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Occurrence and severity of adverse events
Time frame: From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Clinical response rate
Time frame: 8 weeks after end of combination treatment
Dynamic plasma concentration of docetaxel and nedaplatin
Time frame: From start of week 1 to the end of combination treatment (6.5 weeks)
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