NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedBiliary cancer
Date of first enrollment2008/02/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeFeasibility, safety, and disease free survival
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPulmonary 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

Contact

public contact
Name Shogo Kobayashi
Address yamadaoka 2-2, Suita, Osaka, Japan Japan
Telephone
E-mail 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
E-mail
Affiliation Osaka National Hospital Surgery