Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced biliary tract cancer.

UMIN ID: UMIN000000625

Registered date:03/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: locally advanced unresectable biliary tract cancer
• Date of first enrollment: 2007/03/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15. The cycle was repeated every 4 weeks until disease progression or unacceptable toxicity is remarked.
5 weeks concurrent chemo-radiation therapy (CCRT). CCRT is combined radiation (total dose 50 Gy /25 fractions) and weekly Gemcitabine (250mg/m2 administered with 30-min intravenous infusion). 2weeks after CCRT, same protocol with Gemcitabine monotherapy is started.

Outcome(s)

• Primary Outcome: a survival rate for 1 year
• Secondary Outcome: response rate/ safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients with interstitial pneumonia, pulmonary fibrosis. 2.Patients with intractable diabetes mellitus, liver dysfunction, angina pectoris, or myocardinal infarction within months after onset. 3.Patients with suspicious of serious infection, or serious infection. 4.Patients with pregnacy, during lactation, or patient with hope of pregnant 5.Patients with severe drug allergy 6.Patients with severe concomitant disease 7.Patients with pleural effusion or ascites 8.Patients with active multiple cancers 9.The patients judged inappropriate in enrolling into this study by the investigators

Related Information

• Primary Sponsor: First Dept. Internal Medicine Gifu University Hospital
• Secondary Sponsor: Gifu Municipal Hospital, Gifu Prefecural General Medical Center, Takayama Red Cross Hospital
• Source(s) of Monetary Support: None