UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007819 |
|---|---|
| Receipt number | R000009128 |
| Scientific Title | A randomized phase II study of daily administrations versus alternate-day administrations of TS-1 for the elderly patient with completely resected pathological stage IA(T1bN0M0)-IIIA of non-small cell lung cancer |
| Date of disclosure of the study information | 2012/04/25 |
| Last modified on | 2023/07/23 14:36:22 |
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Basic information
Public title
A randomized phase II study of daily administrations versus alternate-day administrations of TS-1 for the elderly patient with completely resected pathological stage IA(T1bN0M0)-IIIA of non-small cell lung cancer
Acronym
A randomized phase II study of TS-1 adjuvant chemotherapy for the elderly patient with completely resected NSCLC
Scientific Title
A randomized phase II study of daily administrations versus alternate-day administrations of TS-1 for the elderly patient with completely resected pathological stage IA(T1bN0M0)-IIIA of non-small cell lung cancer
Scientific Title:Acronym
A randomized phase II study of TS-1 adjuvant chemotherapy for the elderly patient with completely resected NSCLC
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 evaluate the feasibility and efficacy of alternate-day administrations of TS-1 as adjuvant chemotherapy in elderly patients with completely resected p-stage IA(T1bN0M0)-IIIA non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility (treatment completion rate), which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more.
Key secondary outcomes
toxicity, RFS, and 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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:TS-1 alternate-day administrations; TS-1 is administered orally at Monday, Wednesday, Friday and Sunday for one year.
Interventions/Control_2
B: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
| 75 | years-old | <= |
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(T1bN0M0)-IIIA
4) At least lobectomy, within 8 weeks after surgery
5) LN dissection (ND2a)
6) Neither previous chemotherapy nor radiotherapy before operation
7) Age of 75 years or older at the time of enrollment
8) ECOG PS 0-1
9) Adequate organ function:
i) WBC >=3000/mm3 and <=12000/mm3,
ii) PaO2 >= 60mmHg or SpO2 >= 90%
iii) Platelets >=100,000/mm3,
iv) Hemoglobin >=9.0g/dL,
v) Total bilirubin <=1.5mg/dL,
vi) AST(GOT)/ALT(GPT) <=100IU/L,
vii) Creatinine clearance >=40mL/min.
viii) Creatinine < 1.2mg/dl
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
100
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
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs061180089
Org. issuing International ID_1
jRCT (Japan Registry of Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山大学病院（岡山県）
倉敷中央病院（岡山県）
福島県立医科大学附属病院（福島県）
川崎医科大学附属病院（岡山県）
広島市立広島市民病院（広島県）
中国中央病院（広島県）
日本赤十字社長崎原爆病院（長崎県）
長良医療センター（岐阜県）
岡山済生会総合病院（岡山県）
佐賀県医療センター好生館（佐賀県）
京都大学医学部附属病院（京都府）
岡山労災病院（岡山県）
岩国医療センター（京都府）
島根県立中央病院（島根県）
四国がんセンター（愛媛県）
山口宇部医療センター（山口県）
下関市立市民病院（山口県）
鳥取大学医学部附属病院（鳥取県）
呉医療センター 中国がんセンター（広島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0285273#sec019
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0285273
Number of participants that the trial has enrolled
101
Results
We enrolled 101 patients in which 97 patients received S-1 treatment. The treatment completion rate at 6 months was 69.4% in Arm A and 64.6% in Arm B (p = 0.67). Among adverse events, anorexia, skin symptoms and lacrimation of any grade were significantly more frequent in Arm B compared with Arm A (p = 0.0036, 0.023 and 0.031, respectively). The 5-year RFS was 56.9% and 65.7% for Arm A and B, respectively (p = 0.22). The 5-year OS was 68.6% and 82.0% for Arm A and B, respectively (p = 0.11).
Results date posted
| 2023 | Year | 07 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 19 | Day |
Baseline Characteristics
Pathological stage IA (T1bN0M0)/IB/II/IIIA cases with pathologically diagnosed non-small cell lung cancer.
Cases whose age is 75 years or older at the time of enrollment.
Participant flow
Upon enrollment, each patient was randomly assigned to a treatment by Dr. Keitaro Matsuo, Department of Preventive Medicine, Kyushu University Faculty of Medical Sciences, Fukuoka, Japan.
Random assignment was performed using a minimization method with the following adjustment factors: pStage [stage IA (T1bN0M0)/IB or IIA/IIB or IIIA], histology (squamous cell carcinoma or non-squamous cell carcinoma), epidermal growth factor (EGFR) mutational status (positive or negative) and institution.
Patients were randomly assigned to one of the two regimens for S-1; S-1 was administered on Monday, Wednesday, Friday and Sunday of every week (alternate-day administration, Arm A) or daily for 2 weeks followed by a 1-week rest (daily administration, Arm B).
Adverse events
Among adverse events, anorexia, skin symptoms and lacrimation of any grade were significantly more frequent in Arm B compared with Arm A (p = 0.0036, 0.023 and 0.031, respectively).
Outcome measures
The primary endpoint was feasibility (treatment completion rate), which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more.
The secondary endpoints were toxicity, RFS, and OS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009128
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