UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014018 |
|---|---|
| Receipt number | R000016325 |
| Scientific Title | Adjuvant Chemotherapy with Gemcitabine for Resected Biliary Tract Cancer: A Single-Arm Phase II Study |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2014/06/03 18:41:07 |
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Basic information
Public title
Adjuvant Chemotherapy with Gemcitabine for Resected Biliary Tract Cancer: A Single-Arm Phase II Study
Acronym
GEMAC
Scientific Title
Adjuvant Chemotherapy with Gemcitabine for Resected Biliary Tract Cancer: A Single-Arm Phase II Study
Scientific Title:Acronym
GEMAC
Region
| Japan |
Condition
Condition
histologically verified biliary tract cancer (BTCs) with macroscopic complete resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The assessment to the efficacy and safety of adjuvant therapy with gemcitabine in patients with resected BTCs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year disease-free survival (DFS) rate
Key secondary outcomes
2-year overall survival (OS) rate, tolerability, and the frequency of grade 3 or 4 toxicity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine(GEM)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with histologically verified BTC who had macroscopic complete resection and no prior chemotherapy or radiotherapy (patients who had undergone adjuvant radiotherapy were not excluded if at least 4 weeks had passed since the last administration) were eligible for this study.
Other eligibility criteria included as follows: 20 years <= age < 80 years; Eastern Cooperative Oncology Group performance status of 0-2; adequate bone marrow function (leucocyte count >= 4,000/mm3, neutrophil count >= 2,000/mm3, hemoglobin >= 10g/dl, and platelet count >=100,000/mm3), liver function (serum albumin >= 3.0g/dl, total bilirubin <= 2 times the upper limit of normal (ULN) and aspartate aminotransferase [AST]/alanine aminotransferase [ALT] <= 3 times ULN) and renal function (creatinine <= 1.0 mg/dL); life expectancy >= 3 months.
All patients provided written informed consent.
Key exclusion criteria
Exclusion criteria included contracting active infection, syncronous cancer, pregnancy or lactation, a history of severe drug allergy and other severe comorbid diseases including hemopericardium or symptomatic brain metastasis.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Miyagawa |
Organization
Shinshu University
Division name
Gastroenterological Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2654
shinichi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kobayashi |
Organization
Shinshu University
Division name
Gastroenterological Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2654
Homepage URL
kbys@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 06 | Month | 01 | 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
| 2006 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 21 | Day |
Last modified on
| 2014 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016325
