A phase II trial of Neoadjuvant and adjuvant chemotherapy with Gemcitabine and TS-1 combination for patients with locally advanced pancreatic cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: 1)Neoadjuvant chemotherapy: 3 course of gemcitabine and s‐1 combination therapy (21days for one course:day1‐14 S‐1 60mg/m2, day8 and 15 gemcitabine 1g/m2) 2)Surgical resection 3)Adjuvant therapy: 8 course of gemcitabine and s‐1 combination therapy (21days for one course:day1‐14 S‐1 50mg/m2, day8 and 15 gemcitabine 0.8g/m2) CONDITION: pancreatic cancer PRIMARY OUTCOME: R0 resection rate SECONDARY OUTCOME: resection rate (R0+1), overall survival, disease free survival, pathological chemotherapy effect, adverse events, recurrence type, tumor marker, relative dose intensity, tumor response rate, surgical morbidity INCLUSION CRITERIA: 1)Invasive ductal carcinoma or invasive intraductal papillary‐mucinors carcinoma proved by Radiological examination (enhanced CT or MRI) 2)No distant metastasis 3)Borderline or unresectable locally advanced pancreatic cancer tumor abutment of the SMA, HA, CEA tumor involving PV or SMV (diameter of encased PV or SMV are less than 50% of adjacent normal PV or SMV diameter. 4)patients who can tolerate the pancreatic surgery. 5)Age 20 or more 6)No history of primary chemo therapy and/or radiation therapy. 7)ECOG performance status 0‐1 8)Adequate organ function 9)Without problems for oral medication 10) Written informed consent
Epistemonikos ID: d282b83eb7d6e211ab1bc92fcf079dff1c03fa82
First added on: Aug 22, 2024