UMIN-CTR Clinical Trial

Public title

Prospective observational study of the neurocognition in patients treated with prophylactic cranial irradiation in limited stage small cell lung cancer.

Acronym

LOGIK1901

Scientific Title

Prospective observational study of the neurocognition in patients treated with prophylactic cranial irradiation in limited stage small cell lung cancer.

Scientific Title:Acronym

LOGIK1901

Region

Japan

Condition

small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the impact of prophylactic cranial irradiation on cognitive function in patients with limited disease small cell lung cancer

Basic objectives2

Others

Basic objectives -Others

･Change in MMSE score at 4,12,24, and 36 months from the enrollment
･Change in QOL score at 4,12,24 and 36 months from the enrollment
･Rate of brain metastases
･Overall survival
･To explore the risk factors for PCI-induced impairment of cognitive function

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in MMSE score at 24 months from the enrollment

Key secondary outcomes

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 histologically or cytologically diagnosed as small-cell lung cancer
2)Patients who diagnosed as limited disease
3) Patients treated with radical chemoradiotherapy
4) Patients without brain metastasis after radical chemoradiotherapy
5)Within 28 days after final chemotherapy or radiotherapy irradiation
6)PS 0 -2
7)Patients providing the written informed consent
8)Patients with life expectancy of at least 6 months

Key exclusion criteria

1)Patients with less than or equal to 23 points of MMSE score
2)Any other patients who are regarded as unsuitable for this study by the principal investigator or sub-investigators.
3)Patients who refuse the participation in the study
4)Patients who did not respond to chemoradiation
5)Patients who cannot answer the questionnaire and MMSE
6)Patients treated with operation for LD-SCLC

Target sample size

90

Name of lead principal investigator

1st name	Katsuhiko/Jiichiro
Middle name
Last name	Naoki /Sasaki

Organization

Kitasato University School of Medicine

Division name

Department of Respiratory Medicine/Research and Development Center for New Medical Frontiers

Zip code

252-0374

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan

TEL

042-778-8506

Email

knaoki@pg7.so-net.ne.jp

Name of contact person

1st name	Yoshiro
Middle name
Last name	Nakahara

Organization

Kitasato University School of Medicine

Division name

Department of Respiratory Medicine

Zip code

252-0374

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan

TEL

042-778-8506

Homepage URL

Email

md100062@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

Kitasato University School of Medicine

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan

Tel

042-778-8506

Email

md100062@kitasato-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

114

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

No longer recruiting

Date of protocol fixation

2019

Year

06

Month

14

Day

Date of IRB

2019

Year

06

Month

26

Day

Anticipated trial start date

2019

Year

07

Month

01

Day

Last follow-up date

2026

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

0.1Assessment before enrollment
(1)Baseline characteristics
Birth date (Y/M),gender,age,height,weight, clinical stage, primary lesion site, anamnesis, smoking history, performance status, complication, history of concurrent chemoradiation or successive chemoradiation (chemotherapy regimen, date of chemotherapy, thorax irradiation starting date/finishing date, and thorax irradiation dose and fractionation), starting date of PCI
(2)Test within 28 days before enrollment
1)MMSE
2)QOL(FACT-L)
3)Brain metastasis (MRI or CT)
4)Performance Status
5)Subjective and objective symptom (such as dyspnea, anorexia, nausea, vomiting, malaise, cough, wheezing, pain, insomnia, anxiety is evaluated based on CTCAE Ver5.0 [JCOG/JSCO version])
6)Clinical test (HbA1c, creatinine, T-Bil, AST, ALT, albumin, LDH)

Registered date

2019

Year

09

Month

10

Day

Last modified on

2023

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043276