UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer
Acronym	A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer
Scientific Title	A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer
Scientific Title:Acronym	A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the feasibility and efficacy of alternate-day administrations of S-1 as adjuvant chemotherapy with completely resected p-stage I (T>2cm)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Feasibility
Key secondary outcomes	Safety, RFS, OS

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: S-1 alternate-day administrations; S-1 is administered orally at Monday, Wednesday, Friday and Sunday for one year.
Interventions/Control_2	B: S-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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathologically proven non-small cell lung cancer 2) Neither previous chemotherapy nor radiotherapy before operation 3) Complete resection 4) Pathological stage I (T>2cm) 5) LN dissection (ND2a) 6) Aged 20-75 years old enrollment 7) ECOG PS 0-1 8) Adequate organ function: 1. WBC >=3000/mm3 2. Neutrophil count >= 1,500 /mm3 3. Platelet count >= 100,000 /mm3 4. Hemoglobin >= 9.0 g/dL 5. total bilirubin <= 1.5 mg/dL 6. AST and ALT x 2.5 of upper limit of normal (ULN) 7. Creatinine clearance >=40mL/min 8. PaO2 >= 60mmHg or SpO2 >= 90% 9) At least lobectomy, within 8 weeks after surgery 10) Signed informed consent
Key exclusion criteria	1) Allergy against S-1 2) Severe myelosuppression, renal dysfunction or liver dysfunction 3) Usage of other fluorinated pyrimidine drugs 4) Usage of flucytosine 5) Severe drug allergy 6) Unstable angina or Myocardial Infarction within 6 months 7) Apparent interstitial pneumonitis or pulmonary fibrosis at chest rentogenogram 8) Concomitant therapy Warfarin Potassium or Dabigatran 9) Abnormality of EGG or UCG 10) Severe heart disease, serious psychiatric illness, severe infection, severe other complications 11) Uncontrolled Diabetes Mellitus 12) Ileus 13) Diarrhea 14) Uncontrolled cancer 15) HBs antigen positive 16) Other patients who are unfit for the study as determined by the attending physician.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Toyooka
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	General Thoracic Surgery and Breast and Endocrinological Surgery
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-223-7151
Email	toyooka@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Hiromasa Middle name Last name Yamamoto
Organization	Setouchi Lung Cancer Group
Division name	Department of Thoracic Surgery, Okayama University Hospital
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-223-7151
Homepage URL
Email	h.yamamoto@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 Certified Review Board
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel	086-235-6503
Email	ouh-crrb@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	岩国医療センター（山口県） 愛媛大学医学部附属病院（愛媛県） 岡山大学病院（岡山県） 岡山済生会総合病院（岡山県） 川崎医科大学総合医療センター（岡山県） 川崎医科大学附属病院（岡山県） 南岡山医療センター（岡山県） 京都大学医学部附属病院（京都府） 長良医療センター（岐阜県） 倉敷中央病院（岡山県） 福島県立医科大学附属病院（福島県） 中国中央病院（広島県） 鳥取大学医学部附属病院（鳥取県） 広島市立広島市民病院（広島県） 山口宇部医療センター（山口県） 関西医科大学附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 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	93
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	Main results already published
Date of protocol fixation	2013 Year 09 Month 30 Day
Date of IRB	2013 Year 11 Month 19 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 08 Day
Last modified on	2021 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014019