Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
- Conditions
- pancreatic cancer with ascites
- Registration Number
- JPRN-UMIN000003269
- Lead Sponsor
- ational Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method adverse events, response rate, progression free survival, efficacy against ascites