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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000180
Receipt No. R000000253
Scientific Title A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer
Date of disclosure of the study information 2005/09/12
Last modified on 2018/10/03

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Basic information
Public title A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer
Acronym Pilot study of 3 dimensional stereotactic radiotherapy and oral UFT for stage IB NSCLC.
Scientific Title A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer
Scientific Title:Acronym Pilot study of 3 dimensional stereotactic radiotherapy and oral UFT for stage IB NSCLC.
Region
Japan

Condition
Condition non - small cell lung cancer, stageIB.
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of maintenance therapy with oral UFT for two years from the 57th day after 3 dimensional stereotactic radiotherapy (3D-SRT) for patients with stage IB non - small cell cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 3-year survival
Key secondary outcomes Progression free survival, median
survival time, local progression free survival time, local progression free survival at 3 years, pattern of progression or recurrence, adverse events, 5-year survival rate, local progression free survival at 5 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral UFT 250mg/m2 therapy for two years from the 57th day after 3 dimensional stereotactic radiotherapy (3D-SRT) which consists of consecutive 4 days of 12 Gray irradiation per fraction per day (total 48Gy)
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed non-small cell lung cancer
2)Stage IB
3)No previous pulmonary irradiation
4)ECOG PS 0-2
5)Measurable lesions(<5cm)
6)Lesion in the lung
7)20<=Age<85
8)Adequate organ function
Hb>10g/dL, 3000/mm31,500/mm3, Platelet count> 12000/mm3, GOT and GPT<100IU/ml, T-bilirubin<2mg/dl, serum creatinine<1.5mg/dl, PaO260>Torr (room air), FEV1.0>700ml, %VC>50%, ejection fraction>60%
9)Life expectancy for more than 6 months
10)An inoperable patient or patient who refuses operation
11)Written informed consent
Key exclusion criteria 1)Apparent interstitial pneumonitis or fibrosis on chest X ray
2)Irradiation field larger than half of a ipsilateral lung
3)Double cancer within 5 years except for carcinoma in situ, intramucosal tumor, and basal cell carcinoma of the skin
4)History of previous chemotherapy
5)Pregnant woman, lactating woman, woman who has a possibility of pregnancy
6)Uncontrolled angina pectoris, myocardial infarction and congestive heart failure within three months
7)Uncontrolled diabetes mellitus
8)Active infectious disease
9)Fever more than 38 degrees Celsius
10)Steroid administration
11)Other complication unsuitable for the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Institute of Biomedical Research and Innovation
Division name Department of Translational Research Division of Integrated Oncology
Zip code
Address 2-2 Minatomajima-Minamimachi Chuo-ku Kobe 650-0047, Japan
TEL 078-304-5200
Email

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Naya
Organization Institute of Biomedical Research and Innovation
Division name Department of Translational Research Division of Integrated Oncology
Zip code
Address 2-2 Minatomajima-Minamimachi Chuo-ku Kobe 650-0047, Japan
TEL 078-304-5200
Homepage URL
Email naya@kcgh.gr.jp

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor Kobe City General Hospital
Kobe City West Hospital
Nishikobe Medical Center
Hyogo Medical Center for Adults
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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 12 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
2004 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2004 Year 12 Month 01 Day
Last follow-up date
2011 Year 10 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
2005 Year 09 Month 12 Day
Last modified on
2018 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000253

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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