UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016086 |
|---|---|
| Receipt number | R000018679 |
| Scientific Title | Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer |
| Date of disclosure of the study information | 2014/12/30 |
| Last modified on | 2021/02/25 14:37:23 |
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Basic information
Public title
Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer
Acronym
S-1 for adjuvant chemotherapy in NSCLC
Scientific Title
Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer
Scientific Title:Acronym
S-1 for adjuvant chemotherapy in NSCLC
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
The purpose of this study is to determine the feasible adjuvant therapy administration schedule of S-1 for completely resected non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative rate of total administration days of S-1, relative dose intensity, and adverse events
Key secondary outcomes
Three-year-relapse free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm A receiving oral S-1 of 4-week administration followed by 2-week rest for 12 months
Interventions/Control_2
Arm B receiving oral S-1 of 2-week administration followed by 1-week rest for 12 months
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) Completely resected non-small cell lung cancer
2) Adenocarcinma, large cell carcinoma, squamous cell carcinoma, or adeno-squamous cell carcinoma
3) Stage IB-IIIA
4) Age 20-75 year-old
5) ECOG Perfomance Status 0-1
6) Adequate organ function
7) Able to start within 9 weeks after the surgery
8) No prior therapy
9) Written informed concent
Key exclusion criteria
1) Interstitial pneumonia
2) Pleural effusion, ascites, cardiac effusion
3) Active double malignancies
4) Serious medical complications
5) Diarrhea
6) Pregnancy, breastfeeding or suspected of being pregnant
7) Male with intent of reproduction
8) Drug allergy
9) Allergy to ingredients of S-1
10) Administering fluorinated pyrimidine other than S-1
11) Administering flucytosine
12) Others judged by attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iyoda |
Organization
Toho University Omori Medical Center
Division name
Division of Chest Surgery
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3752-4151
aiyoda@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Hata |
Organization
Toho University Omori Medical Center
Division name
Division of Chest Surgery
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3752-4151
Homepage URL
hata@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Chest Surgery, Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Division of Chest Surgery, Toho University Omori Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Surgery, Toho University Ohashi Medical Center
Division of Surgery, Toho University Sakura Medical Center
Department of Thoracic Surgery, National Defense Medical College Hospital
Department of Thoracic and Cardiovascular Surgery, Self-Defense Forces Central Hospital
Division of Respiratory Medicine, Toranomon Hospital
Respiratory Diseases Center, International University of Health and Welfare, Mita Hospital
Department of Thoracic Surgery, Mitsui Memorial Hospital
Division of Thoracic and Cardiovascular Surgery, Showa University School of Medicine
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
the Ethics Committee of Toho University Omori Medical Center
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151
somu.omori@jim.toho-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
| 2014 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28851314
Number of participants that the trial has enrolled
80
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 08 | Month | 29 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2004 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2014 | Year | 12 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018679
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