pancreatic cancer
Conditions
Interventions
S1: bid d1-7 q2w x 12 courses PO GEM: d1 q2w x 12 courses DIV The doses of GEM and S-1 in the phase II trial are determined based on the results of the phase I trial.
Sponsors
Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven pancreatic adenocarcinoma 2)Gross complete resection (R0 or R1) 3)No prior chemotherapy or radiotherapy 4)Age between 20 and 79 years 5)ECOG performance status of 0 or 1 6)Adequate hematologic, hepatic and renal function 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Watery diarrhea 2)Severe mental disorder 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Symptomatic pulmonary fibrosis or interstitial pneumonia 6)History of radiation therapy to the chest 7)Marked pleural or peritoneal effusion 8)Active concomitant malignancy 9)Treatment with phenytoin, potassium warfarin or flucytosine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: the maximum-tolerated dose and dose-limiting toxicity of GS therapy. Phase II: overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: adverse events and disease-free survival. | — |
Countries
Japan
Contacts
Public ContactTomoo Kosuge
Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer National Cancer Center Hospital, HBP Surgery Division
Outcome results
None listed