UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Nobuyuki Katakami
Organization	Institute of Biomedical Research and Innovation
Division name	Department of Translational Research Division of Integrated Oncology
Address	2-2 Minatomajima-Minamimachi Chuo-ku Kobe 650-0047, Japan
TEL	078-304-5200
Email

Public contact
Name of contact person	Reiko Naya
Organization	Institute of Biomedical Research and Innovation
Division name	Department of Translational Research Division of Integrated Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 11 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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