UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001750 |
|---|---|
| Receipt number | R000002109 |
| Scientific Title | A phase II study of gemcitabine and TS-1 in erderly patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2009/03/05 |
| Last modified on | 2016/04/04 15:42:35 |
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Basic information
Public title
A phase II study of gemcitabine and TS-1 in erderly patients with advanced non-small cell lung cancer
Acronym
Gemcitabine and TS-1 in erderly patients with non-small cell lung cancer
Scientific Title
A phase II study of gemcitabine and TS-1 in erderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Gemcitabine and TS-1 in erderly patients with non-small cell lung cancer
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safty of gemcitabine and TS-1
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Safty, Overall survival, Progression-free survival
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
Gemcitabine and TS-1 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
| 70 | 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 of radiation therapy, and Stage IV
3)age range more than 70 years
4)ECOG performance status of 0 or 1
5)a life expectancy of 12 weeks or more
6)Measurable by RECST criteria
7)no previous chemotherapy or radiotherapy
8)adequate bone marrow, liver, and renal functions
WBC > 4000 mm-3
Neutro > 2000 mm-3
Platlets > 100000 mm-3
Hb > 9 g dL-1
T-Bil< 1.5 mg dL-1
AST, ALT<100IU/L
s-Cr < 1.5 mg dL-1
CCr > 60 mL min-1
PaO2>70torr
9)Written informed consent
Key exclusion criteria
1)Pulmonary fibrosis detectable on chest X-ray films
2)Massive pleural effusion, ascites and pericardial effusion required drainage
3)Concomitant malignancy
4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome
5)Symptomatic brain metastasis
6)Pregnant or milk-feeding female. Intention to be pregnant in the future
7)With severe allergy
8)Other clinical difficulties to this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Sunaga |
Organization
Gunma University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan
TEL
027-220-7111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Sunaga |
Organization
Gunma University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan
TEL
027-220-7111
Homepage URL
nsunaga@showa.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
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
| 2009 | Year | 03 | Month | 05 | 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
| 2008 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 03 | Day |
Last modified on
| 2016 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002109
