UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001020 |
|---|---|
| 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 |
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Basic information
Public title
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Acronym
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Scientific Title
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Scientific Title:Acronym
Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer
Region
| Japan |
Condition
Condition
Biliary cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the administration schedule of gemicitabine in the patient undergoing curative resection of biliary cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Feasibility, safety, and disease free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant chemotherapy with 6 cycle of gemcitabine on days 1, 8, and 15 every 4 weeks
Interventions/Control_2
Adjuvant chemotherapy with 9 cycle of gemcitabine on days 1 and 8 every 3 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion 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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Miyamoto |
Organization
Osaka National Hospital
Division name
Surgery
Zip code
Address
Hoenzaka 2-1-14, Chuoku, Osaka City, Osaka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka University
Division name
GI Surgery
Zip code
Address
yamadaoka 2-2, Suita, Osaka, Japan
TEL
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Biliary Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Osaka University, Department of GI Surgery
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
J Cancer Ther 2011; 2: 703-709.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2007 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 06 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001180
