A randomized phase II study designed to compare toxicity and dose intensity between four-week versus three-week schedule of gemcitabine for advanced pancreatic cancer
Not Applicable
- Conditions
- Advanced nonresectable pancreatic cancer
- Registration Number
- JPRN-UMIN000000974
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria are as follows: active infection, intestinal pneumoniae or lung fibrosis, severe complication such as liver cirrhosis and heart disease, active concomitant malignancy, pregnant or lactating females, females of childbearing age, sever drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance rate of protocol regimen (The rate is the proportion of patients without grade 3 to 4 hematological toxicity or grade 2 to 4 non-hematological toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) ver3.0, within eight weeks after initiation of chemotherapy. )
- Secondary Outcome Measures
Name Time Method Dose intensity 1 year survival rate Median survival time Response Rate Time to progression Time to treatment failure Karnofsky - perfomance status Adverse effects