Feasibility and efficacy of preoperative chemoradiation and postoperative liver perfusion chemotherapy for T3 (UICC) pancreatic cancer

UMIN ID: UMIN000001804

Registered date:27/03/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer ; T3 of UICC TNM classification of malignant tumours 6th edition)
• Date of first enrollment: 2002/05/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemoradiation EXRT 50Gy gemcitabine 1000mg/m2 Liver perfusion chemotherapy 5FU 125mg/day via hepatic artery, 125mg/day via portal vein for 4 weeks (continuous infusion) or gemcitabine 1g via portal vein 1/w for 3-4weeks

Outcome(s)

• Primary Outcome: safety, survival
• Secondary Outcome: pathological response, pattern of failure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: unusual running of hepatic artery, renal dysfunction, sever coronary disease, past history of malignant disease or chronic hepatitis, white blood cell count<3000/mm3, platelet count <104/mm3, Activated partial thromboplastin>50sec, ALT,AST>100U/l creatinine>1.5mg/dl

Related Information

• Primary Sponsor: Osaka Medical Center for cancer & Cardiovascular Diseases gastrointestinal & hepatobiliary- pancreatic surger
• Source(s) of Monetary Support: Osaka Medical Center for cancer & Cardiovascular Diseases gastrointestinal & hepatobiliary- pancreatic surger