UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000001255