The latest guidelines recommend Gemcitabine plus Capecitabine as the first choice of adjuvant chemotherapy for pancreatic cancer patients in good physical condition. In order to prolong the survival of patients and improve the cure rate, metronomic chemotherapy with capecitabine is a safe, effective and economical treatment mode after adjuvant chemotherapy. This study is trying to determine that compared with observation group, if capecitabine metronomic medication is a better choice after adjuvant chemotherapy.
Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used in adjuvant therapy for pancreatic cancer. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 500mg/m2, and maintain for a whole year after the standard treatment in stage II/III pancreatic cancer patients. 1 year disease-free survival is set as the primary outcome, OS, RFS, AEs and exploratory biomarkers including effects of metronome chemotherapy on immune cells, such as NK cells, T cells, TAMs, B cells, etc are also observed as the secondary outcomes. Statistical analysis are made to see compared with observation group, whether this metronomic therapy of capecitabine ( 500mg/m2) will bring benefit to pancreatic cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
231
Oral fluorouracil
Department of Oncology, Ruijin Hospital
Shanghai, China
RECRUITINGOne year disease-free survival
was defined as the rate of disease recurrence, metastasis or death due to disease progression within 1 year after the surgery
Time frame: 1 year
Overall Survival (OS)
was defined as the time from the date of surgery until the date of any death occurred
Time frame: 5 year
Recurrence-free Survival (RFS)
was defined as the time from the date of surgery until the date of local recurrence of the tumor
Time frame: 1 year
AEs
Hand and foot syndrome and other treatment related AE
Time frame: 5 year
Exploratory biomarkers
including effects of metronome chemotherapy on immune cells, such as NK cells, T cells, TAMs, B cells, etc
Time frame: 1 yaer
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