UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000180 |
|---|---|
| Receipt number | 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 14:00:15 |
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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/mm3
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
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
naya@kcgh.gr.jp
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000253
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