UMIN-CTR Clinical Trial

Basic information
Public title	A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602)
Acronym	A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602)
Scientific Title	A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602)
Scientific Title:Acronym	A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602)
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Completion Rate of S-1 administration & radiotherapy
Key secondary outcomes	Adverse events, Grade 2 or greater radiation pneumonitis,Overall survival rate at 2 years, Disease-free survival rate at 2 years, Local control rate at 2 years

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 80 mg/m2 (daily oral administration) for 2 weeks with stereotactic body radiation therapy 48 Gy/ 4 fractions
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.Histologically or transbronchoscopic cytologically or Clinically(exe. FDG-PET) confirmed non-small cell lung cancer 2.StageI-IIA(T1-2b, N0, M0) with images 3.No prior therapy for the disease 4.Aged 20<= years 5.ECOG performance status of 0-2 6.Required baseline laboratory parameters (within 2 weeks before registration): 1)PaO2 >= 60Torr 2)FEV1.0 >= 700 ml 3)Neu >= 1,500/ mm3 4)Hb >= 10g/dl 5)Plt >= 100,000/ mm3 6)AST < 100IU/ml 7)ALT < 100IU/ml 8)T-Bil <= 2.0mg/dl 9)Cre <= 1.5mg/dl 10)Creatinine Clearance >= 60ml/min 11)Written informed consent
Key exclusion criteria	1.Apparent interstitial pneumonitis and fibrosis 2.Active inflammation without oral drugs 3.Double cancer 4.Pregnancy 5.Psychiatric disorder 6.Steroid administration 7.Oxygen administration 8.Fever of 38.0 degrees centigrade or higher
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Tomonari Middle name Last name Sasaki
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Division of Quantum Radiation Sciences, Department of Health Sciences
Zip code	8128582
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka City, Fukuoka
TEL	092-642-6726
Email	tomonari@hs.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Tomonari Middle name Last name Sasaki
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Division of Quantum Radiation Sciences, Department of Health Sciences
Zip code	8128582
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka City, Fukuoka
TEL	092-642-6726
Homepage URL
Email	tomonari@hs.med.kyushu-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Lung Oncology Group in Kyushu (LOGIK)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Hospital Clinical Trial Ethics Review Committee
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka City, Fukuoka
Tel	092-642-5774
Email	byshinsa@jimu.kyushu-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	九州大学病院（福岡） 国立病院機構九州がんセンター（福岡県） 福岡大学病院（福岡県） 大分県立病院（大分県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 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	1
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	Terminated
Date of protocol fixation	2018 Year 04 Month 05 Day
Date of IRB	2018 Year 05 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 11 Day
Last follow-up date	2021 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 23 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037283