UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037978
Receipt number R000043276
Scientific Title Prospective observational study of the neurocognition in patients treated with prophylactic cranial irradiation in limited stage small cell lung cancer.
Date of disclosure of the study information 2019/09/10
Last modified on 2023/09/13 09:07:35

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Basic information

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

Condition

small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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



Assessment

Primary outcomes

Change in MMSE score at 24 months from the enrollment

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


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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Support Center Kyushu

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

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

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)


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name