UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005058 |
|---|---|
| Receipt number | R000006014 |
| Scientific Title | Phase II study of S-1 chemotherapy in elderly patients with advanced non-small cell lung cancer harboring no EGFR gene mutation |
| Date of disclosure of the study information | 2011/02/14 |
| Last modified on | 2011/05/17 13:22:53 |
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Basic information
Public title
Phase II study of S-1 chemotherapy in elderly patients with advanced non-small cell lung cancer harboring no EGFR gene mutation
Acronym
Phase II study of S-1 chemotherapy in elderly patients with advanced non-small cell lung cancer harboring no EGFR gene mutation (ALCSG 1002)
Scientific Title
Phase II study of S-1 chemotherapy in elderly patients with advanced non-small cell lung cancer harboring no EGFR gene mutation
Scientific Title:Acronym
Phase II study of S-1 chemotherapy in elderly patients with advanced non-small cell lung cancer harboring no EGFR gene mutation (ALCSG 1002)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The present study evaluates the efficacy and safety of single-agent S-1 in elderly patients with advanced NSCLC harboring no EGFR gene mutation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate.
Key secondary outcomes
Disease control rate, overall survival, progression free survival, safety.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
single agent S-1
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
Eligibility includes; 1) patients having a histological or cytological diagnosis of NSCLC, 2) NSCLC at clinical stage IIIA to IV, 3) patients aged 70 and over 70 years, 4) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, 5) patients having adequate organ function, 6) no prior chemotherapy for NSCLC, 7) NSCLC harboring no EGFR gene mutation, 8) life expectancy of longer than 3 months.
Key exclusion criteria
Patients are excluded if they have; 1) severe concomitant diseases, 2) interstitial pneumonia, 3) NSCLC with EGFR gene mutations, 4) no measurable lesion.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Ohsaki |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
TEL
Homepage URL
okumura-@asahikawa-med.ac.jp
Sponsor or person
Institute
Respiratory Center, Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Center, Asahikawa Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa Lung Cancer Study Group (ALCSG)
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
旭川医科大学病院（北海道）、旭川医療センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 09 | Day |
Last modified on
| 2011 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006014
| 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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