UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001294 |
|---|---|
| Receipt number | R000001564 |
| Scientific Title | Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer |
| Date of disclosure of the study information | 2008/08/08 |
| Last modified on | 2015/11/25 17:41:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Acronym
Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Scientific Title
Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Scientific Title:Acronym
Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Region
| Japan |
Condition
Condition
Biriary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Efficacy
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
Administration of gemcitabine and cisplatin for adjuvant chemotherapy
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
Histologically proven biliary tract cancer after surgical resection
Stage IB,IIA, IIB,III (UICC)
R0 and R1
No previous chemo- or radiotherapy within 3 years
Within 8 weeks after operation
PS 0 and 1
Hb >=10g/dl
WBC >=3000/mm3
Neutrophil >=1500/mm3
Platelet >=100,000/mm3
AST, ALT <=150U/L
T-Bil <=3mg/dl
CCr >=45ml/min
Key exclusion criteria
Apparent infection
Fever
Heart disease
Interstitial pneumonia, pulmonary fibrosis
Other active cancers
Brain metastasis
Pericardial effusion
Allergy of the drugs
Pregnancy or patient's hope to be pregnant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehide Asano |
Organization
National Hospital Organization Chiba-East-Hospital
Division name
Department of Surgery
Zip code
Address
673 Nitona, Chuo-ku, Chiba, Japan
TEL
043-261-5171
asano@cehpnet.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Kainuma |
Organization
Chiba Cancer Center
Division name
Gastroenterological Surgery
Zip code
Address
666-2 Nitona, Chuo-ku, Chiba, Japan
TEL
043-264-5431
Homepage URL
okainuma@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
帝京大学病院(東京都）、千葉県がんセンター(千葉県）、東海大学病院（神奈川県）、千葉東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1868-6982
Number of participants that the trial has enrolled
Results
Among 29 evaluable patients, the protocol was completed in 21 (72%) patients. Relative dose intensity (RDI) of gemcitabine and CDDP was 77% and 81%, respectively. There was no difference in the completion rate and the RDI between patients who underwent resection with vs. without major hepatectomy. Grade 3-4 toxicities included leukopenia
(14%) and neutropenia (27%). Two-year RFS and 2-year OS was 59% and 90%, respectively.
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
| 2007 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 04 | Day |
Last modified on
| 2015 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001564
