metastatic pancreatic adenocarcinoma
Conditions
Interventions
S-1(40~60mg)+LV(25mg) orally twice daily for 1 week, followed by 1-week rest
Sponsors
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as invasive ductal adenocarcinoma by enhanced abdominal CT or overall observation 2) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenosquamous carcinoma by the biopsy or cytology of pancreatic tumor or metastatic sites 3) Metastatic pancreatic adenocarcinoma with mesurable lesion according to Response evaluation criteria in solid tumors (RECIST) guideline version 1.1 4) Without CNS metastasis 5) Without moderate or more ascites/pleural effusion 6) Aged 20 to 75 years old 7) ECOG PS of 0 or 1 8) No previous therapy for pancreatic adenocarcinoma, except for a recurrence after 6 months since the end of adjuvant chemotherapy with gemcitabine 9)No previous chemotherapy or radiotherapy against any other malignancies 10) Sufficient oral intake 11)Adequate organ functions 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Required to continue to take flucytosine, phenytoin, and warfarin 2) Active infections 3) High fever(over 38 degrees) 4) Severe complications (heart failure, myocardial infarction, renal failure, liver cirrhosis, ileus, interstitial lung disease, uncontrolled diabetes, cerebrovascular disorder, severe mental disorder, and so on) 5)Uncontrollable watery diarrhea or severe bowel disorder 6) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 7) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 8) Patients requiring systemic steroids medication 9) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy 10) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival overall survival adverse events serious adverse events | — |
Countries
Japan
Contacts
Public ContactAkiko Todaka
JASPAC03 Coordinating Office Shizuoka Cancer Center, Division of GI Oncology
Outcome results
None listed