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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001754
Receipt No. 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

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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
Email 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
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Hepato-biliary pancreatic surgery,Tohoku University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002093

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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