JPRN-UMIN000003269
Completed
Phase 2
Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites. - Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
ational Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division0 sites36 target enrollmentMarch 1, 2010
Conditionspancreatic cancer with ascites
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- pancreatic cancer with ascites
- Sponsor
- ational Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Not specified
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