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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010501
Receipt No. R000012279
Scientific Title Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II study
Date of disclosure of the study information 2013/04/15
Last modified on 2016/05/13

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Basic information
Public title Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II study
Acronym Adjuvant chemotherapy using gemcitabine+ CDDP
Scientific Title Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II study
Scientific Title:Acronym Adjuvant chemotherapy using gemcitabine+ CDDP
Region
Japan Asia(except Japan) North America

Condition
Condition resected bile duct cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy of cisplatin + Gemcitabine chemotherapy as adjuvant chemotherapy for resected bile duct cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes disease free survival
Key secondary outcomes

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 GEM+CDDP study
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 1) Bile duct cancer, pathological diagnosis as adenocarcinoma including adenoaquamous cell carcinoma,
Stage is I-IV and R 0-1 resection.
2)Patients never had chemo-radiation therapy.
3) registration within 10 week after operation.
4)PS is 0-1
5)Good oral intake
6)no ascites and distance metastasis
7)clear of age limited
8)pass the criteria as below
Hb 3000/mm3, WBC 3000/mm3, Plt 10,000/mm3
AST,ALT 150IU/L, T-Bli 3.0mg.dl, Cr 1.2mg/dl,
9) get informed consent
Key exclusion criteria 1)Recurrence before registration
2)evidence of ascites and pleural effusion.
3)Evidence of cardiac effusion
4)Patients have pneumonia or pleural fibrosis.
5)Uncontrolled diarrhea
6)No evidence of OMI 3 months before registration.
7) No viral hepatitis
8)Uncontrolled DM
9)No BTF 2 week before registration.
10)There are not complication, such as cardiac, renal failure and/or liver failure, peptic ulcer, bowel pararitic disorder and stable for mental status.
11)no allergy.
12)No evidence of other organ malignancy.


Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Kubota
Organization Dokkyo Medical Uniiversity
Division name Second department of Surgey
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2158
Email shimodamtisugi@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mitsugi Shimoda
Organization Dokkyo Medical Uniiversity
Division name Second department of Surgey
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2158
Homepage URL
Email shimodamitsugi@hotmail.com

Sponsor
Institute Dokkyo Medical Uniiversity
Institute
Department

Funding Source
Organization none
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
2013 Year 04 Month 15 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 Terminated
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 15 Day
Last modified on
2016 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012279

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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