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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014018
Receipt No. 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

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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
Email 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
Email kbys@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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