Resected pancreatic cancer
Conditions
Interventions
Patients receive gemcitabine (1,000 mg/m2, days 1, 8 and 15) every 4 weeks. This cycle is repeated for six months or until relapse is confirmed.
Patients receive gemcitabine (800 mg/m2, day 1) plus S
Sponsors
Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven invasive ductal carcinoma of the pancreas 2) Macroscopically curative resection (R0, R1) 3) No metastasis 4) No history of prior chemotherapy or radiotherapy for pancreatic cancer 5) Age 20 to 79 years 6) ECOG performance status of 0 or 1 7) Adequate organ function 8) Written informed consent 9) Within 10 weeks after surgery
Exclusion criteria
Exclusion criteria: 1) History of serious complications related to surgery 2) Patients under treatment with phenytoin, warfarin potassium or flucytosine. 3) Uncontrolled watery diarrhea 4) Sever mental disorder 5) Active infection 6) Serious complications 7) Pulmonary fibrosis or interstitial pneumonia 8) Clinically significant pleural effusions or ascites 9) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 2 years or less) 10) History of chemotherapy or radiotherapy for other malignant disease within one year 11) Unable to receive contrast enhanced CT nor MRI due to allergic reaction to contrast medium 12) Pregnant females, possibly pregnant females, females wishing to become pregnant, and males that are currently attempting to produce a pregnancy 13) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactHideki Ueno
National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Divison
Outcome results
None listed