UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility Study of Adjuvant Chemotherapy with UFT Following Stereotactic Body Radiation Therapy for Clinical Stage I Non-Small Cell Lung Cancer (LOGIK-1001)
Acronym	Feasibility Study of UFT following Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer. (LOGIK-1001)
Scientific Title	Feasibility Study of Adjuvant Chemotherapy with UFT Following Stereotactic Body Radiation Therapy for Clinical Stage I Non-Small Cell Lung Cancer (LOGIK-1001)
Scientific Title:Acronym	Feasibility Study of UFT following Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer. (LOGIK-1001)
Region	Japan

Condition
Condition	Clinical Stage I Non-small Cell Lung Cancer Treated with Stereotactic Body Radiation Therapy
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of adjuvant UFT following stereotactic body radiation therapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Completion Rate of UFT therapy
Key secondary outcomes	Adverse events, Grade 2 or greater radiation pneumonitis, Disease-free survival, Overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	UFT250 mg/m2(daily oral administration)for 2years
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.StageIB(T1-2a, N0, M0) with images 3.Undergone curative stereotactic body radiation therapy 4.No prior therapy other than stereotactic body radiation therapy 5.Aged 20<= years. 6.ECOG performance status of 0-1. 7.Required baseline laboratory parameters (within 2 weeks before registration): WBC >= 3000/mm3 Neu >= 1,500/ mm3 Hb >= 10g/dl Plt >= 100,000/ mm3 GOT < 100IU/ml GPT < 100IU/ml T-Bil <= 2.0mg/dl Cre <= 1.5mg/dl PaO2 >= 60Torr 8.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	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukito Ichinose
Organization	National Hospital, Kyushu Cancer Center
Division name	Department of Thoracic Oncology
Zip code
Address	3-1-1 Notame, Minami-ku, Fukuoka, 811-1395
TEL	092-541-3231
Email	yichinos@nk-cc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshiyuki Shioyama
Organization	Kyushu University, Graduate School of Medical Sciences
Division name	Department of Heavy Particle Therapy and Radiation Oncology
Zip code
Address	3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL	092-642-5695
Homepage URL
Email	shioyama@radiol.med.kyushu-u.ac.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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（福岡県） 浜の町病院（福岡県） 福岡大学病院（福岡県） 国立病院機構 福岡東医療センター（福岡県） 済生会福岡総合病院（福岡県） 飯塚病院（福岡県） 国立病院機構　大牟田病院（福岡県） 北九州市立医療センター（福岡県） 新別府病院（大分県） 大分県立病院（大分県） 九州大学病院別府先進医療センター（大分県） 長崎大学病院（長崎県） 熊本大学病院（熊本県） 沖縄県立南部医療センター・こども医療センター（沖縄県）

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 24 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
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	Completed
Date of protocol fixation	2010 Year 03 Month 24 Day
Date of IRB	2011 Year 01 Month 14 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 12 Month 24 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005695