UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007624 |
|---|---|
| Receipt number | 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 20:53:38 |
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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
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
yagi-to@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009002
