UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004789 |
|---|---|
| Receipt number | R000005695 |
| 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) |
| Date of disclosure of the study information | 2010/12/24 |
| Last modified on | 2021/02/15 14:25:41 |
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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
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
shioyama@radiol.med.kyushu-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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005695
