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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008462
Receipt No. 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

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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
Email 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
Email esophagus@jikei.ac.jp

Sponsor
Institute Jikei university of medicine department of oncology and hematology, department of digestive surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009947

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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