UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032693 |
|---|---|
| Receipt number | R000037283 |
| 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) |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/01/05 10:47:20 |
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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
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
tomonari@hs.med.kyushu-u.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037283
