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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011994
Receipt No. R000014019
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
Date of disclosure of the study information 2013/12/01
Last modified on 2020/10/15

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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 Unpublished

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 No longer recruiting
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
2020 Year 10 Month 15 Day


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

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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