Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, China
RECRUITINGDisease free survival
Time frame: From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: from randomization to 1 month after end of treatment
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