UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002592 |
|---|---|
| Receipt number | R000003169 |
| Scientific Title | A feasibility study of postroperative adjuvant chemotherapy using platinum-based chemotherapy followed by maintenance TS-1 for completely resected pathologic stage II-IIIA non-small cell lung cancer with a biomarker study of circulating tumor cell |
| Date of disclosure of the study information | 2009/10/07 |
| Last modified on | 2010/04/07 10:11:03 |
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Basic information
Public title
A feasibility study of postroperative adjuvant chemotherapy using platinum-based chemotherapy followed by maintenance TS-1 for completely resected pathologic stage II-IIIA non-small cell lung cancer with a biomarker study of circulating tumor cell
Acronym
Feasibility study of postoperative maintenance TS-1 chemotherapy and a biomarker study of CTC in NSCLC
Scientific Title
A feasibility study of postroperative adjuvant chemotherapy using platinum-based chemotherapy followed by maintenance TS-1 for completely resected pathologic stage II-IIIA non-small cell lung cancer with a biomarker study of circulating tumor cell
Scientific Title:Acronym
Feasibility study of postoperative maintenance TS-1 chemotherapy and a biomarker study of CTC in NSCLC
Region
| Japan |
Condition
Condition
Completely resected pathologic stage II-IIIA non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate feasibility of adjuvant chemotherapy using platinum-based chemotherapy followed by maintenance TS-1 administration for completely resected p-stage II-IIIA non-small cell carvinoma, and to assess clinical significance of circulating tumor cell (CTC) as a biomarker
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Compliance of maintenance TS-1 administration following platinum-based chemotherapy in postoperative adjuvant setting
Key secondary outcomes
Safety profile, Didsease-free survival; Overall survival; CTC-count in correlation with clinical outcome
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
Maintenance TS-1 administration following platinum-based chemotherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically-proven non-small cell lung cancer
2) Completery resected pathologic stage II-IIIA (UICC-7th)
3) No previous treatment for lung cancer
4) Performance status 0-1 (ECOG)
5) Good major organ function
6) age, 20years or higher
7) Written informed consent
Key exclusion criteria
Active other malignant disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | FUMIHIRO TANAKA |
Organization
HYOGO COLLEGE OF MEDICINE
Division name
THORACIC SURGERY
Zip code
Address
MUKOGAWA 1-1, NISHINOMIYA
TEL
+81-798-45-6885
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | FUMIHIRO TANAKA |
Organization
HYOGO COLLEGE OF MEDICINE
Division name
THORACIC SURGERY
Zip code
Address
TEL
Homepage URL
ftanaka@hyo-med.ac.jp
Sponsor or person
Institute
DEPARTMENT OF THORACIC SURGERY, HYOGO COLLEGE OF MEDICINE
Institute
Department
Personal name
Funding Source
Organization
DEPARTMENT OF THORACIC SURGERY, HYOGO COLLEGE OF MEDICINE
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2010 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003169
