pancreatic cancer with ascites
Conditions
Interventions
Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicit
Sponsors
National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pancreatic cancer histologically confirmed as adenocarcinoma or adenosquamous carcinoma. 2) Patients with mild or moderate ascites. 3) Patients with no previous treatment for pancreatic cancer, except resection. 4) Age: 20 years to less than 80 years. 5) ECOG Performance Status(PS) of 0 or 1. 6) Adequate organ functions. 7) Sufficient oral intake. 8) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia or fibroid lung. 2) Watery diarrhea. 3) Active infection, excluding viral hepatitis. 4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). 5) Ascites only localized at pelvic cavity. 6) Massive ascites. 7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 1 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration. 8) Sever ECG abnormality. 9) Patients under treatment with flucytosine, phenytoin or warfarin potassium. 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Sever mental disorder. 12) Inadequate physical condition, as diagnosed by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, response rate, progression free survival, efficacy against ascites | — |
Countries
Japan
Contacts
Public ContactSatoshi Shimizu
National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed