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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001049
Receipt No. R000001255
Scientific Title Adjuvant chemotherapy for completely rsected non-small cell lung cancer with TS-1 - evaluation of predictive factors for prognosis
Date of disclosure of the study information 2008/02/22
Last modified on 2020/09/08

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Basic information
Public title Adjuvant chemotherapy for completely rsected non-small cell lung cancer with TS-1 - evaluation of predictive factors for prognosis
Acronym KOLK-2
Scientific Title Adjuvant chemotherapy for completely rsected non-small cell lung cancer with TS-1 - evaluation of predictive factors for prognosis
Scientific Title:Acronym KOLK-2
Region
Japan

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

Objectives
Narrative objectives1 To identify the predictive factors for TS-1 sensitivity as adjuvant chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes To identify the predictive factors for TS-1 sensitivity as adjuvant chemotherapy
Key secondary outcomes Feasibility and safety

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 TS-1 (80-120mg/day x 14days, q21d X 16 courses) is administrated orally.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) completely resected NSCLC
2) Ad, Sq, Large, AdSq
3) p-Stage IA (>=2.0cm), p-Stage IB
4) age ranged from 20 to 80
5) PS 0-1 (ECOG)
6) sufficient functionn of important organs
a) WBC >= 4000/mm3
b) Neutro >= 2000/mm3
c) Platelet >= 100,000/mm3
d) Hb >= 9.0g/dl
e) AST/ALT <= 2.5 fold of normal ranges in each institute
f) T.Bil <= 1.5mg/dl
g) Cr <= within normal limit
h) CCr >= 50ml/min
i) PaO2 >=70torr or SpO2>=92%
7) administration of TS-1 within 8 weeks after surgery
8) without previous treatment
9) with ability of oral intake
10) with written informed consent
Key exclusion criteria 1) with interstitial change or fobrotic change on chest X ray film or chest CT scan
2) massive pleural effusion or ascites
3) with active double cancer
4) with intractable angina pectoris, myocardial infarction, cardiac failure, intractable diabetes mellitus, hypertension, sever infection, ileus, SVC syndrome, abnormal coagulability
5) watery diarrhea
6) pregnant, nursing woman or woman who is likely to be pregnant
7) men with partner willing to get pregnant
8) with severe drug allergy
9) with hypersensitivity to elements of TS-1
10) under medication with 5-FU
11) under medication with Flucytocine
12) doctor's decision not to be registered to this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nomori
Organization Keio University, School of Medicine
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsutomo Kono
Organization Keio University, School of Medicine
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3806
Homepage URL
Email kohno@1993.jukuin.keio.ac.jp

Sponsor
Institute Division of General Thoracic Surgery,
Keio University, School of Medicine,
Institute
Department

Funding Source
Organization None
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
2008 Year 02 Month 22 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
2008 Year 02 Month 19 Day
Date of IRB
2008 Year 02 Month 19 Day
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2017 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
2008 Year 02 Month 22 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001255

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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