pancreatic cancer
Conditions
Interventions
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
Sponsors
Chiba study group of adjuvant chemotherapy for pancreatic cancer
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) History of sever allergic reaction with gemcitabine or s-1 2)Sever myelosuppression 3) Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 4)Serious renal dysfunction 5)Serious liver dysfunction 6)Patients under treatment with other furuorouracil related chemotherapy 7)Patients under treatment with flucytosine. 8)Pulmonary fibrosis or interstitial pneumonia 9)History of breast or lung radiation 10)Active infection 11)Patients with pleural effusion 12)Evidence of distant metastasis 13)Active double cancer 14)Uncontrolled heart diseases such as angina, myocardial infarction within three months, and cardiac dysfunction 15)Uncontrolled diabetes or hypertension 16)Sever mental disorder 17)Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHideyuki Yoshitomi
Chiba University, Graduate School of Medicine, Chiba Japan Department of General Surgery
Outcome results
None listed