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

UMIN ID: UMIN000000974

Registered date:08/01/2008

Basic Information

• Health condition(s) or Problem(s) studied: Advanced nonresectable pancreatic cancer
• Date of first enrollment: 2006/01/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1, 8 and 15. The cycle was repeated every four weeks until evidence of disease progression, patient refusal or unacceptable toxicity.
Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1 and 8. The cycle was repeated every three weeks until evidence of disease progression, patient refusal or unacceptable toxicity.

Outcome(s)

• Primary Outcome: 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: Dose intensity 1 year survival rate Median survival time Response Rate Time to progression Time to treatment failure Karnofsky - perfomance status Adverse effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Okayama University Hospital
• Source(s) of Monetary Support: None