Resectable pancreatic cancer
Conditions
Interventions
Neoadjuvant chemotherapy with gemcitabine and S-1 followed by surgery and adjuvant with 4 course of oral S-1 (Test arm).
Surgery and adjuvant with 4 course of oral S-1 (Control arm).
Sponsors
Study group of preoperative therapy for pancreatic cancer (PREP)/Japanese Study Group of Adjuvant Therapy for pancreatic Cancer (JSAP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) invasive ductal carcinoma of the pancreas 2) no distant metastasis 3) R0/1 resectable 4) all adult who anticipate to undergo pancreatectomy 5) no prior therapy 6) written informed consent 6) ECOG performance status of 0 or 1 7) Adequate organ function 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) pulmonary fibrosis or interstitial pneumonitis 2) Uncontrolled watery diarrhea 3) Active double cancer 4) Active infection 5) HBs antigen positive 6) Pregnant females, possibly pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Resection rate Phase III: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Adverse events Phase III: Adverse events, Resection rate, Residual tumor, Nodal involvement rate, Histological response, Relapse-free survival, Tumor marker kinetics, Dose intensity, Patterns of Recurrence, Radiological tumor response | — |
Countries
Japan
Contacts
Public ContactFuyuhiko Motoi
Tohoku University Graduate School of Medicine Surgery
Outcome results
None listed