invasive pancreatic ductal adenocarcinoma invasive pancreatic ductal adenocarcinoma, borderline resectable pancreatic cancer
Conditions
Interventions
neoadjuvant gemcitabine plus S-1 based chemoradiotherapy using intensity modulated radiotherapy (IMRT)
Patients receive orally S-1twice daily at a dose of 60mg/m2/day on days 1 through 21 of a 28-day cycle and an infusion of gemcitabine at a dose of 600 mg/m2 on days 8, 22, 36, and 50. Patients will be
Sponsors
Mizuno Shugo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age at the time of registry is 20 o r more, 79 or less 2. newly diagnosed invasive pancreatic ductal adenocarcinoma (PDAC) confirmed by imaging study and histological or cytological studies. 3. no distant metastasis 4. borderline resectable PDAC according to the resectability of Japan Pancreas Society 7th classification based on contrast enhanced multid etector CT imaging. 5. toleable curative resection 6. no previous anti-tumor treatment 7. Eastern Cooperative Oncology G roup performance status, 0, 1 8. adequate hematological, hepatic, renal, and cardiopulmonary functions 9. adequate ability of oral intake 10. written informed consent befor e enrolling the study
Exclusion criteria
Exclusion criteria: Patients who: 1) is allergic to the chemotherapeutic agents. 2) has pulmonary fibrosis or intestinal pneumonia. 3) has active infectious disease. 4) has simulatenous active cancer. 5) is plegnant or has possibility to become pregnant during the study. 6) is considered ineligible for enrolling the study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| histological response (Grade 1, 2, 3, 4) in the resected specimens according to the Japan Pancreas Society 7th classification | — |
Secondary
| Measure | Time frame |
|---|---|
| radiographic response according to revised RECIST guideline, rate of adverse events, rate of curative-intent resection, rate of R0 resection, 2-year and 5-year overall survival rate after curative-intent resection, 2-year and 5-year overall survival rate after initial treatment, rate of postoperative complication, rate of recurrence after surgery, mode of recurrence, reasons why pancreatectomy was evaluated as not indicated, and details of treatment after discontinuation of protocol treatment | — |
Contacts
Public ContactYasuhiro Murata
Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University Hospital
Outcome results
None listed