UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001754 |
|---|---|
| Receipt number | R000002093 |
| Scientific Title | Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients |
| Date of disclosure of the study information | 2009/03/04 |
| Last modified on | 2015/03/09 08:52:48 |
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Basic information
Public title
Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients
Acronym
Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients:NACRAC study
Scientific Title
Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients
Scientific Title:Acronym
Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients:NACRAC study
Region
| Japan |
Condition
Condition
cholangiocarecinoma:Stage III and IV of the Japanese General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase II trial of neoadjuvant chemoradiation with gemcitabine and surgical resection for cholangiocarcinoma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
pathological curability
Key secondary outcomes
safety, disease free survival, over all survival, pathological response
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
chemoradiation
EXRT: 45Gy, 1.8Gy x 25 fr
Gemcitabine : 600mg/m2
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
1. Histologically confirmed as cholangiocarcinoma. And Stage III and IV by the Japanese General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract
2. Performancestatus(ECOG) is 0 or 1
3. Age are from 20 years old to 74 yeas old
4. survival is expected over 2 months
5. Function of main organ are enough as below,
Hb over 10 g/dl. WBC is over 4000/mm3. Neutrophil is over 2000/mm3. Platlet is over1x104mm3. AST and ALT are within 5 times of normal limit. Total bilirubin is within 3 times of normal limit. Creatinine is 1.5 times within normal limit.
6. sign the letter of consent by voluntary agreement
Key exclusion criteria
1. obvious infection
2. fever up (over 38 Celsius)
3. severe complication of heart and lung
4. active double cancer
5. synptom of brain metastases
6. pericardial fluid
7. Previous history of severe drug-induced allergy
8. Pregnant
9. Disqualified by attendig doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University Hospital
Division name
Hepato-biliary pancreatic surgery,
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Nakagawa |
Organization
Tohoku University Hospital
Division name
Hepato-biliary pancreatic surgery,
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7205
Homepage URL
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Hepato-biliary pancreatic surgery,Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hepato-biliary pancreatic surgery,Tohoku University Hospital
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
| 2009 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.surg1.med.tohoku.ac.jp/class/hbpcog.html
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 04 | Day |
Last modified on
| 2015 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002093
| 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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