UMIN-CTR Clinical Trial

Public title

Vignette study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)

Acronym

Vignette Study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)

Scientific Title

Vignette study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)

Scientific Title:Acronym

Vignette Study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)

Region

Japan

Condition

Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

1) To investigate which treatment a patient will select between EGFR-TKI and standard doublet chemotherapy, and the reason why patients select each treatment.
2) To investigate the relationship between patient's insight and QOL/HADS score(QOL:FACT-L, HADS: Score for anxiety)
3) To seek any potential gap in treatment selection among patient, physician and other medical staff.

Basic objectives2

Others

Basic objectives -Others

1) To investigate which treatment a patient will select between EGFR-TKI and standard doublet chemotherapy, and the reason why patients select each treatment.
2) To investigate the relationship between patient's insight and QOL/HADS score(QOL:FACT-L, HADS: Score for anxiety)
3) To seek any potential gap in treatment selection among patient, physician and other medical staff.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

To investigate the reason for treatment selection by patients, physician or medical staff.

Key secondary outcomes

To investigate any correlation between patient treatment choice and FACT-L or HADS
To explore any gap in treatment choice between patients and physicians or medical staff.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who are proven non-small cell lung cancer harboring EGFR mutations, acceptable for drug treatment and with written informed consent for this study
2) Doctors or Medical staff working on lung cancer treatment with written informed consent for this study

Key exclusion criteria

1) Patients who have previously treated with standard platinum doublet chemotherapy, single chemotherapy for elderly or EGFR-TKI

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Yukito Ichinose

Organization

Kyushu Cancer Center

Division name

Department of Thoracic Oncology

Zip code

Address

3-1-1 Notame, Minami-ku, Fukuoka, 811-1395, Japan

TEL

092-541-3231

Email

Name of contact person

1st name
Middle name
Last name	Jiichiro Sasaki

Organization

Faculty of Medicine, Kitasato University

Division name

Department of Respiratory Medicine

Zip code

Address

1-15-1 Kitasato, Minami-ku, Sagamihara-city, Kanagawa, 252-0374, Japan

TEL

042-778-6412

Homepage URL

Email

saji@med.kitasato-u.ac.jp

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

飯塚病院呼吸器内科（福岡県）
大分県立病院呼吸器外科（大分県）
長崎大学熱研内科(長崎県)
川内市医師会立市民病院呼吸器内科(鹿児島県)
浜の町病院呼吸器内科（福岡県）
長崎市立市民病院内科（長崎県）
九州大学呼吸器科（福岡県）
産業医科大学呼吸器内科（福岡県）
国立病院機構福岡東医療センター呼吸器科（福岡県）
国立病院機構九州がんセンター呼吸器腫瘍科（福岡県）
熊本市民病院呼吸器科（熊本県）
福岡大学筑紫病院（福岡県）
熊本大学呼吸器内科（熊本県）
佐賀大学血液・呼吸器・腫瘍内科（佐賀県）
熊本医療センター呼吸器内科（熊本県）
日本赤十字社長崎原爆病院呼吸器内科（長崎県）

Date of disclosure of the study information

2010

Year

04

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

12

Month

12

Day

Date of IRB

Anticipated trial start date

2010

Year

03

Month

01

Day

Last follow-up date

2012

Year

11

Month

30

Day

Date of closure to data entry

2012

Year

12

Month

28

Day

Date trial data considered complete

2012

Year

12

Month

28

Day

Date analysis concluded

2013

Year

01

Month

24

Day

Other related information

1) To investigate which treatment a patient will select between EGFR-TKI and standard doublet chemotherapy, and the reason why patients select each treatment.

Registered date

2010

Year

04

Month

22

Day

Last modified on

2013

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004271