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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003204
Receipt No. R000003884
Scientific Title UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer
Date of disclosure of the study information 2010/02/17
Last modified on 2017/05/26

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Basic information
Public title UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer
Acronym UFT maintenance after complete resection for lung cancer
Scientific Title UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer
Scientific Title:Acronym UFT maintenance after complete resection for lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate UFT maintenance after platinum base adjuvant chemotherapy for completely resected non-small lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Completion rate of 2-year UFT adminsitration
Key secondary outcomes Safety, disease-free survival duration,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 UFT daily for 2 years
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 proven non-small lung cancer.
2)Complete resection histologically.
3)Platinum base chemothrapy 1=< courses as prior adjuvant chemotherapy.
4)20 years old or older.
5)Performance status(ECOG)=0-2
6)WBC>=2,000 and <=12,000/mm3
Neutrophil>=1,000mm3
Platlet>=75,000/mm3
T Bil<=1.5mg/dL
AST/ALT<=100 IU/L
PaO2>=70mmHg

7)Written informed consent
Key exclusion criteria 1)history of Allergy to UFT
2)History of lung fibrosis or intersittial pneumonistis
3)Active infectious diseases
4)Seviour diarrhea
5)Pre-operation or history of non-platinum adjuvant chemotherapy
6)Concomitant malignancy
7)No match for includion criteria within 8 weeks after prior adjuvant chemotherpy
8)No pregnant or nursing
9)Other uncontrolled medical illness
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Sawada
Organization Shikoku Cancer Center
Division name Thracic surgery
Zip code
Address 190 Minamiumemotocho-Ko, Matsuyama, Ehime 791-0280, Japan
TEL +81-89-999-1111
Email ssawada-ths@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Sawada
Organization Shikoku Cancer Center
Division name Thoracic Surgery
Zip code
Address 160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
TEL +81-89-999-1111
Homepage URL
Email ssawada-ths@umin.ac.jp

Sponsor
Institute Thracic Surgery
Shikoku Cancer Center
Institute
Department

Funding Source
Organization Shikoku Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 17 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 No longer recruiting
Date of protocol fixation
2010 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 17 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003884

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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