UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010501 |
|---|---|
| Receipt number | 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 15:50:00 |
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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
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
shimodamitsugi@hotmail.com
Sponsor or person
Institute
Dokkyo Medical Uniiversity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
