UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000598 |
|---|---|
| Receipt number | R000000725 |
| Scientific Title | Adjuvant Chemotherapy With Gemcitabine in Patients Undergoing Curative-Intent Resection of Biliary Cancer: a Phase I/II Trial |
| Date of disclosure of the study information | 2007/02/07 |
| Last modified on | 2011/02/26 06:55:31 |
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Basic information
Public title
Adjuvant Chemotherapy With Gemcitabine in Patients Undergoing Curative-Intent Resection of Biliary Cancer: a Phase I/II Trial
Acronym
Adjuvant Chemotherapy With Gemcitabine in Biliary Cancer
Scientific Title
Adjuvant Chemotherapy With Gemcitabine in Patients Undergoing Curative-Intent Resection of Biliary Cancer: a Phase I/II Trial
Scientific Title:Acronym
Adjuvant Chemotherapy With Gemcitabine in Biliary Cancer
Region
| Japan |
Condition
Condition
Biliary Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the safety and efficacy of a postoperative regimen with gemcitabine in patients undergoing curative-intent resection of biliary cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Safety
Phase II: Feasibility
Key secondary outcomes
Phase II: Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks
Interventions/Control_2
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with histologically verified biliary cancer who had macroscopic complete resection (>=stage II) and no prior radiation or chemotherapy
ECOG Performance Status 0-1
Adequate organ function (leukocytes>=4.0 X 109/L, neutrophils>=2.0 X 109/L, platelets>=100 X 109/L, hemoglobin>=9 g/dl, total bilirubin<=2 X upper limit of normal (ULN), AST, ALT<=4 X ULN, serum creatine<=ULN
No fever with infection
Adverse events other than blood/bone marrow<=grade 2 according to National Cancer Institute - Common Terminology Criteria for Adverse Events v3.0
Written informed consent
No major postoperative complication
Tolerable to chemotherapy within 12 weeks after surgery
Key exclusion criteria
Pulmonary fibrosis or interstitial pneumonia with radiological or clinical findings
Uncontrollable pleural effusion
Uncontrollable diabetes mellitus or liver dysfunction
With distant metastasis except lymph node metastasis
With uncured other malignancies
Active infection
Severe major postoperative complication such as peritonitis and massive bleeding
With active peptic ulcer
A history of myocardial infarction within 3 months
Psychiatric disorder
Pregnant or breast-feeding women, Women wishing for baby
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Graduate School of Medicine
Kyoto University
Division name
Department of Surgery
Zip code
Address
54 Kawaharacho Shogoin Sakyoku Kyoto
TEL
075-751-3234
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
54 Kawaharacho Shogoin Sakyoku Kyoto
TEL
075-751-3234
Homepage URL
etsu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery
Graduate School of Medicine
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery
Graduate School of Medicine
Kyoto University
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
| 2007 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Completed
Date of protocol fixation
| 2007 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 07 | Day |
Last modified on
| 2011 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000725
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