UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002383 |
|---|---|
| Receipt number | R000002925 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer |
| Date of disclosure of the study information | 2009/08/25 |
| Last modified on | 2013/03/25 16:42:02 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Acronym
Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Scientific Title
Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Scientific Title:Acronym
Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Surgery in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of patients who accomplished S-1 therapy of eight courses.
Key secondary outcomes
Adverse events
The relative total administration dose of S-1
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant chemotherapy of eight courses
(2-week administration and 1-week withdrawal): S-1 dose of 67mg/m2 twice daily
Interventions/Control_2
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed NSCLC
2)p-Stage IB, II and III & complete resection
3)No prior treatment
4)Adjuvant chemotherapy within 4-8 weeks
5)ECOG PS 0-1
6)Age 70 or older
7)Adequate organ function
8)Written informed consent
Key exclusion criteria
1)Past history of drug hypersensitivity
2)Past history of myocardial infarction within 6 months
3)Interstitial pneumonia or active lung fibrosis
4)Uncontrolled heart diseases
5)Uncontrolled psychiatric disorders
6)Uncontrolled diabetes
7)Bowel problems
8)Active infection
9)Severe complications
10)Active concomitant malignancy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukito Ichinose |
Organization
National Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
Fukuoka
TEL
092-541-3231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Ebi |
Organization
Iizuka Hospital
Division name
Department of respiratory medicine
Zip code
Address
TEL
0948-22-3800
Homepage URL
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
飯塚病院（福岡県）、新日鐵八幡記念病院（福岡県）、大分県立病院（大分県）、熊本地域医療センター（熊本県）、長崎大学病院（長崎県）、浜の町病院（福岡県）、国立病院機構大牟田病院（福岡県）、九州大学（福岡県）、熊本大学（熊本県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 25 | 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
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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 25 | Day |
Last modified on
| 2013 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002925
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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