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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007624
Receipt No. R000009002
Scientific Title Piolt study of usefulness of analysis of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in safety of paclitaxel for the patients with alcohol intolerance
Date of disclosure of the study information 2012/04/01
Last modified on 2018/10/29

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Basic information
Public title Piolt study of usefulness of analysis of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in safety of paclitaxel for the patients with alcohol
intolerance
Acronym Role of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in the alcohol-related toxicity of paclitaxel
Scientific Title Piolt study of usefulness of analysis of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in safety of paclitaxel for the patients with alcohol
intolerance
Scientific Title:Acronym Role of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in the alcohol-related toxicity of paclitaxel
Region
Japan

Condition
Condition Breast cancer, gastric cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, esophageal cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We analyze genetic polymorphism of ALDH2 in patients with malignant disease (breast cancer, gastric cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, esophageal cancer) to see the correlation between genetic status of ALDH2(ALDH2*1/*1 and ALDH2*1/*2 ) and frequency and grade of alcohol-related toxicity of paclitaxel.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Completion rate of two cycles of weekly paclitaxel
Key secondary outcomes 1) Rate of genetic polymorphism of ALDH2, 2) frequency and grade of alcohol associated symptoms after paclitaxel injection, 3)time course of breath alcohol concentration (BAC)

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 Patients with ALDH2*1/*1 will be injected paclitaxel for 1 hour, and patients with ALDH2*1/*2 will be injected it for three hours.Frequency and grade of alcohol associated symptoms will be checked after paclitaxel injection.
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)ECOG scale: PS0-2
2)Patient with enough feasibility for planned chemotherapy which contains paclitaxcel (hematological, liver, renal, cardiopulmonary function)
3)Patient suspected to have intolerance for alcohol on medical interview, e.g. patient who feel uneasy about taking a glass of beer ( about 180ml)
4)Written informed consent
Key exclusion criteria 1)Pregnancy, the possibility of pregnancy or breast feeding.
2)Patients unable to take paclitaxcel because of significant cardiovascular abnormalities, renal dysfunction, hepatic insufficiency, uncontrolled hypertension, uncontrolled diabetes, bleeding tendency, active interstitial pneumonia ,etc.
3)Febrile patients who are suspected to be infected.
4)Prior treatment with paclitaxcel
5)Patients unable to comply with the protocol, in the opinion of the investigator.
6)Other contraindication to paclitaxcel.
(1)severe myelosuppression
(2)Known hypersensitivity to paclitaxcel or drugs which contain polyoxyethylene caster oil (e.g. ciclosporin injection).
(3) Patient taking disulfiram, cyanamide, carmofur, and procarbazine hydrochloride.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinari Yagi
Organization Osaka International Cancer Institute
Division name Department of Clinical Oncology
Zip code
Address 3-1-69 Otemae, Chuo-ku,Osaka 541-8567 Japan
TEL 06-6945-1181
Email yagi-to@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinari Yagi
Organization Osaka International Cancer Institute
Division name Department of Clinical Oncology
Zip code
Address 3-1-69 Otemae, Chuo-ku,Osaka 541-8567 Japan
TEL 06-6945-1181
Homepage URL
Email yagi-to@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 大阪国際がんセンター大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s12282-018-0918-9
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 Completed
Date of protocol fixation
2012 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2016 Year 01 Month 14 Day
Date of closure to data entry
2016 Year 01 Month 14 Day
Date trial data considered complete
2016 Year 01 Month 14 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 30 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009002

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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