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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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