UMIN-CTR Clinical Trial

Basic information
Public title	Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)
Acronym	TS-1 for p-stage IA NSCLC(SLCG0701)
Scientific Title	Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)
Scientific Title:Acronym	TS-1 for p-stage IA NSCLC(SLCG0701)
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 assess the efficacy and toxicity of two modified medication of S-1 adjuvant therapy for completely resected pathological stage IA (T1>2cm) non-small cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	drug compliance
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A:TS-1 day1-28, q2w for one year
Interventions/Control_2	A:TS-1 day1-14, q1w for one year
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) pathologically proven Non Small Cell Lung Cancer 2) complete resection 3) pathological stage IA (T1>2cm) 4) at least lobectomy, within 4 to 6 weaks after surgery 5) LN dissection (ND2a) 6) no prior anti cancer treatment for thoracic malignancy except for this operation 7) ECOG PS 0-1 8) adequate organ function 9) oral intake 10) Signed informed consent
Key exclusion criteria	1. sever infection, uncontrolled Diabetes Mellitus, and hypertension 2. unstable angina or Myocardial Infarction within 6 months 3. apparent interstitial pneumonitis at chest rentogenogram 4. systemic steroid therapy required 5. uncontrolled cancer 6. Pregnant or expecting woman 7. serious psychiatric illness 8. usaige of other fluorinated pyrimidine drugs 9. Concomitant therapy with flucytocine, phenytoin or Warfarin Potassium
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Hiroshi Middle name Last name Date
Organization	Graduate School of Medicine Kyoto University
Division name	Thoracic Surgery
Zip code	606-8507
Address	54 Kawara-machi Seigoin Sakyoku, Kyoto, Kyoto 606-8507, Japan
TEL	0757513111
Email	hdate@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Shinichi Middle name Last name Toyooka
Organization	Setouchi Lung Cancer Group
Division name	Okayama University, Cancer and Thoracic Surgery
Zip code	700-8558
Address	2-5-1 Shikata-cho Kita-ku Okayama
TEL	086-235-7265
Homepage URL
Email	toyooka@md.okayama-u.ac.jp

Sponsor
Institute	Setouchi Lung Cancer Group
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	Okayama University IRB
Address	2-5-1 Shikata-cho Okayama, Okayama 700-8558, Japan
Tel	086-235-6762
Email	mae6605@adm.okayama-u.ac.jp

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	2011 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

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	2007 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2007 Year 06 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	2011 Year 12 Month 27 Day
Last modified on	2019 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008213