UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002994 |
|---|---|
| Receipt number | R000003630 |
| Scientific Title | Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2010/01/07 |
| Last modified on | 2010/01/07 21:15:34 |
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Basic information
Public title
Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Acronym
Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Scientific Title
Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of TS-1 in elderly non-small cell lung cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
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
TS-1:65mg/m2/day-80mg/m2/day
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically Proven non-small cell lung cancer
2)Stage IIIB with no induction radiation therapy,or Stage IV
3)Age range older than 75
4)No previous chemotherapy surgery or radiotherapy
5)Measurable by RECIST criteria
6)Adequate bone narrow,liver, and renal functions
Hb:over9.0g/dl
WBC:4000-12000mm3
Neutro:over2000mm3
PLT:over100000/mm3
T-Bil:underNUMx1.5
AST,ALT:under100IU
Ccr:over30ml/min
PaO2:over60mmHg
7)ECOG Performance status of 0-2
8)Life expectancy of 12 weeks or more
9)Nomal EKG
10)Written informed concent
Key exclusion criteria
1)Serious medical complications
2)Patients with active lung disease such as interstitial pneumonia, pulmonary fibrosis
3)Massive pleural effusion,ascites and penicardial effusion requires drainage
4)Symptomatic brain metastasis
5)History of severe allergy
6)Received radiotherapy to primary region
7)Concomitant malignancy
8)Other clinical difficulties to this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Yamaji |
Organization
Mitoyo General Hospital
Division name
Chest Physician
Zip code
Address
708 Himehama Toyohama Kan-onji Kagawa 769-1695 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagawa University School of Medicine
Division name
First Department of Medicine
Zip code
Address
TEL
087-891-2145
Homepage URL
Sponsor or person
Institute
Kagawa TGO Study 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
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2005 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | 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
| 2010 | Year | 01 | Month | 07 | Day |
Last modified on
| 2010 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003630
