Phase I/II study of arterial infusion of 5-fluorouracil combined with systemic gemcitabine for unresectable pancreatic cancer

UMIN ID: UMIN000000573

Registered date:16/01/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable pancreatic cancer
• Date of first enrollment: 2006/10/01
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive arterial infusion of 5-FU via an indwelling catheter and port system and systemic GEM at day 1,8, and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Outcome(s)

• Primary Outcome: Adverse reaction
• Secondary Outcome: Response rate, progression-free survival and over all surval

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)distant metastaes except of liver and node 2)adequate drug distribution via celiac arterial infusion with alteration of pancreatic blood flow will not be achieved 3)Interstitial pneumonia in chest X-ray 4)active gastro-duodenal ulcer 5)Allergic reaction to iodine contrast material. 6)Infectious disease with fever over 38 degree Celcius or antibiotics required. 7)Pregnant or nursing. 8)Severe drug allergic reaction 9)The other severe complicated disease

Related Information

• Primary Sponsor: Nara Medical University
• Source(s) of Monetary Support: non