UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006164 |
|---|---|
| Receipt number | R000007285 |
| Scientific Title | Study of UGT1A1*27 gene polymorphism for irinotecan therapy |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2021/02/17 19:56:58 |
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Basic information
Public title
Study of UGT1A1*27 gene polymorphism for irinotecan therapy
Acronym
Study of UGT1A1*27 for irinotecan
Scientific Title
Study of UGT1A1*27 gene polymorphism for irinotecan therapy
Scientific Title:Acronym
Study of UGT1A1*27 for irinotecan
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To validate the effect of UGT1A1*27 gene polymorphism against safety and efficacy in irinotecan therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between UGT1A1*27 gene polymorphism and irinotecan adverse effects
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologicaly or cytologicaly confirmed lung cancer
2) scheduled the dose of Irinotecan therapy as follows:
single >= 80mg/m2
combination >= 50mg/m2
radiation with single >= 50mg/m2
radiation with combination >= 40mg/m2
3) age >= 20 year old
4) ECOG PS 0-2
5) Written informed consent
Key exclusion criteria
1) interstitial pneumonia in chest X-ray
2) with active infection
3) with active the other malignancies
4) pregnancy or possible pregnancy
5) mental diesease difficult to attend the study
6) high fever >= 38 degree
7) severe complication: myocardial infarction within 3 months, uncontrolled angina pectoris, heart failure, diabetes mellitus, hypertension
8) diarrhea
9) paralysis of intestine or ileus
Target sample size
111
Research contact person
Name of lead principal investigator
| 1st name | Yukito |
| Middle name | |
| Last name | Ichinose |
Organization
National Kyushu Cancer Center
Division name
Respiratory Division
Zip code
811-1395
Address
3-1-1 Notame, South region, Fukuoka, Japan
TEL
092-541-3231
yichinos@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Fukuda |
Organization
Nagasaki University
Division name
Clinical Oncology centre
Zip code
852-8501
Address
1-7-1,Sakamoto,Nagasaki,852-8501,Japan
TEL
095-819-7779
Homepage URL
mifukuda258@nifty.com
Sponsor or person
Institute
Lung Oncology Group in Kyusyu
Institute
Department
Personal name
Funding Source
Organization
Lung Oncology Group in Kyusyu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Nagasaki Genbaku Hospital
Address
3-15 mori, Nagasaki
Tel
095-847-1511
https://www.nagasaki-med.jrc.or.jp/
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
日本赤十字社長崎原爆病院、長崎大学病院、川内市医師会立市民病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/27385990/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/27385990/
Number of participants that the trial has enrolled
50
Results
Fifty patients were enrolled, with 48 patients determined eligible. UGT1A1 polymorphisms 28/28, 6/6, 28/-, 6/-, -/-, observed 0 (0%), 1(2%), 1(2%), 7(15%), 17(35%), and 22(46%), respectively. UGT1A1*27 were examined in 9 patients including one ineligible patient, however, no polymorphisms were found.
Results date posted
| 2021 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 04 | Month | 05 | Day |
Baseline Characteristics
Male 41 Female 7
Median age 72 range 51-87
PS 0/1/2 = 14/33/1
Participant flow
Fifty patients from two institutions were enrolled between October 2011 and December 2013. Two patients received lower starting doses of irinotecan, which was considered a protocol violation. Thus, the data of 48 patients were finally evaluated for the existence of UGT1A1 gene polymorphisms, toxicity, response, and survival.
Adverse events
Febrile neutropenia was observed at a higher tendency in patients with UGT1A16 (32%) and UGT1A128 (25%) gene polymorphisms, compared with wild type (14%), but had no significant difference.
Outcome measures
Of the 48 patients, 43 were assessable for tumor response. Objective tumor response was observed in 19 patients with an overall response rate of 44%. The tumor response of 57% in UGT1A128 or UGT1A1*6 gene polymorphisms was higher compared with 30% in wild type, but was not statistically different (P = 0.150).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe about relationship UGT1A1*27 gene polymorphism and irinotecan adverse effects
Management information
Registered date
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007285
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/02/17 | 1004B.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/02/17 | 1004B.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/02/17 | 1004B.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/7285
