UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011994 |
|---|---|
| Receipt number | 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 | 2021/10/14 21:31:44 |
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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
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
h.yamamoto@md.okayama-u.ac.jp
Sponsor or person
Institute
Setouchi Lung Cancer Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014019
