Unique ID issued by UMIN | UMIN000001020 |
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Receipt number | R000001180 |
Scientific Title | Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer |
Date of disclosure of the study information | 2008/02/11 |
Last modified on | 2016/02/10 11:30:25 |
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Japan |
Biliary cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To determine the administration schedule of gemicitabine in the patient undergoing curative resection of biliary cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Feasibility, safety, and disease free survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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
20 | years-old | <= |
Not applicable |
Male and Female
Patients with histologically verified biliary cancer who had curetive resection (>=stage II) and no prior therapy.
Performance Status 0-1.
Adequate organ function (Hb >=10g/dL, Leukocyte >=4x103/uL, Neutrophil >=2x103/uL, Platelets>=100x103/uL, AST,ALT <=4xULN, Bil <=2xULN, creatine<=ULN.
Tolerable to chemotherapy within 4-12 weeks after surgery.
Written informed consent.
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.
40
1st name | |
Middle name | |
Last name | Atsushi Miyamoto |
Osaka National Hospital
Surgery
Hoenzaka 2-1-14, Chuoku, Osaka City, Osaka, JAPAN
1st name | |
Middle name | |
Last name | Shogo Kobayashi |
Osaka University
GI Surgery
yamadaoka 2-2, Suita, Osaka, Japan
s-kobayashi@umin.ac.jp
Biliary Cancer Treatment Group
Osaka University, Department of GI Surgery
NO
2008 | Year | 02 | Month | 11 | Day |
Published
J Cancer Ther 2011; 2: 703-709.
Main results already published
2007 | Year | 12 | Month | 28 | Day |
2008 | Year | 02 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2008 | Year | 02 | Month | 06 | Day |
2016 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001180
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