UMIN ID: UMIN000001020
Registered date:11/02/2008
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Biliary cancer |
Date of first enrollment | 2008/02/01 |
Target sample size | 40 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Adjuvant chemotherapy with 6 cycle of gemcitabine on days 1, 8, and 15 every 4 weeks Adjuvant chemotherapy with 9 cycle of gemcitabine on days 1 and 8 every 3 weeks |
Outcome(s)
Primary Outcome | Feasibility, safety, and disease free survival |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | Pulmonary fibrosis or interstitial pnumonia with radiologycal or clinical findings Uncontrollable pleural effusion or ascites or edema. Active severe infection severe complication (e.g. heart failure, renal failure, liver failure, GI ulcer, ileus uncontrollabe diabetes mellitus) severe drug allergy With uncured other malignancies Psychiatric disorder Pregnant or women wishing for baby. |
Related Information
Primary Sponsor | Biliary Cancer Treatment Group |
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Secondary Sponsor | |
Source(s) of Monetary Support | Osaka University, Department of GI Surgery |
Secondary ID(s) |
Contact
public contact | |
Name | Shogo Kobayashi |
Address | yamadaoka 2-2, Suita, Osaka, Japan Japan |
Telephone | |
s-kobayashi@umin.ac.jp | |
Affiliation | Osaka University GI Surgery |
scientific contact | |
Name | Atsushi Miyamoto |
Address | Hoenzaka 2-1-14, Chuoku, Osaka City, Osaka, JAPAN Japan |
Telephone | |
Affiliation | Osaka National Hospital Surgery |