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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005695


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name