Adjuvant Chemotherapy With Gemcitabine in Patients Undergoing Curative-Intent Resection of Biliary Cancer: a Phase I/II Trial

UMIN ID: UMIN000000598

Registered date:07/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Biliary Cancer
• Date of first enrollment: 2007/02/01
• Target sample size: 26
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks

Outcome(s)

• Primary Outcome: Phase I: Safety Phase II: Feasibility
• Secondary Outcome: Phase II: Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Pulmonary fibrosis or interstitial pneumonia with radiological or clinical findings Uncontrollable pleural effusion Uncontrollable diabetes mellitus or liver dysfunction With distant metastasis except lymph node metastasis With uncured other malignancies Active infection Severe major postoperative complication such as peritonitis and massive bleeding With active peptic ulcer A history of myocardial infarction within 3 months Psychiatric disorder Pregnant or breast-feeding women, Women wishing for baby

Related Information

• Primary Sponsor: Department of Surgery Graduate School of Medicine Kyoto University
• Source(s) of Monetary Support: Department of Surgery Graduate School of Medicine Kyoto University