This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Time to progression
Time frame: 12 months
safety
number of patients who experienced grade 3-4 toxicity by NCI-CTCAE
Time frame: 12 months
1 year survival rate
Time frame: 1 year
response rate
response rate by RECIST criteria
Time frame: 1 year
overall survival
Time frame: 1 year
clinical benefit rate
CR+PR+SD by RECIST criteria
Time frame: 1 year
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