UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008462 |
|---|---|
| Receipt number | R000009947 |
| Scientific Title | Interaction analysis between genetic polymorphisms and the efficacy/toxicity of chemotherapy in esophageal cancer |
| Date of disclosure of the study information | 2012/07/18 |
| Last modified on | 2018/07/24 07:33:31 |
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Basic information
Public title
Interaction analysis between genetic polymorphisms and the efficacy/toxicity of chemotherapy in esophageal cancer
Acronym
Interaction analysis between genetic polymorphisms and the efficacy/toxicity of chemotherapy in esophageal cancer
Scientific Title
Interaction analysis between genetic polymorphisms and the efficacy/toxicity of chemotherapy in esophageal cancer
Scientific Title:Acronym
Interaction analysis between genetic polymorphisms and the efficacy/toxicity of chemotherapy in esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association between genetic polymorphisms and the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil chemotherapy in esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
association between XPD, ERCC1, GSTP1,TS genetic polymorphisms and objective response with docetaxel/cisplatin/5-fluorouracil chemotherapy in esophageal cancer
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
Combination chemotherapy with docetaxel/cisplatin/5-fluorouracil (docetaxel 60mg/sm day1, cisplatin 70mg/sm day1, 5-fluorouracil 600mg/sm day 1 to 5) given every 4 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who will receive docetaxel/cisplatin/5-fluorouracil chemotherapy for advanced esophageal cancer
(2) Pathologically proven squamous cell carcinoma of the esophagus (clinical stage II to IV)
(3) Written informed consent is provided
Key exclusion criteria
Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Arakawa |
Organization
Jikei university school of medicine
Division name
Department of oncology and hematology
Zip code
Address
3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan
TEL
03-3433-1111
yarakawa@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Arakawa |
Organization
Jikei university school of medicine
Division name
Department of oncology and hematology
Zip code
Address
3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan
TEL
03-3433-1111
Homepage URL
esophagus@jikei.ac.jp
Sponsor or person
Institute
Jikei university of medicine department of oncology and hematology, department of digestive surgery
Institute
Department
Personal name
Funding Source
Organization
Jikei university of medicine department of oncology and hematology, department of digestive surgery
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
| 2012 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009947
| 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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