UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000098 |
|---|---|
| Receipt number | R000000147 |
| Scientific Title | Gemcitabine / Docetaxel combination chemotherapy for non-small cell lung cancer patient of safety confirmation test research |
| Date of disclosure of the study information | 2010/12/31 |
| Last modified on | 2005/08/31 16:03:00 |
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Basic information
Public title
Gemcitabine / Docetaxel combination chemotherapy for non-small cell lung cancer patient of safety confirmation test research
Acronym
Safety test on GEM/DOC combination chemotherapy to NSCLC
Scientific Title
Gemcitabine / Docetaxel combination chemotherapy for non-small cell lung cancer patient of safety confirmation test research
Scientific Title:Acronym
Safety test on GEM/DOC combination chemotherapy to NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gemcitabine/Docetaxel combination chemotherapy for non-small cell lung cancer patient and confirmation of safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine / Docetaxel
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The example of treating Mi in the non-small cell lung cancer and patients who obtained the conviction according to the cytology the organization and looking after cannot excision patient who has untreated disease and recurrent disease
2.Case of PS 0-2
3.Patient of Omoats abnormality of hepatic function and kidney function who not is
(a)Cr<1.5mg/dl, Ccr>50ml/min
(b)T.Bil<2.0mg/dl,GOT,GPT<2xupper normal limit
4.The number of 4000 of the leukocyte count or more before it treats and the number of 2000 of neutrophil count or more, and the number of platelets is 100000 or more, and Hb 10.0/dl or more.
5.Case who obtained agreement by document
6.Have the change to a morbid state that can be measured or can evaluated for the survival time of three months
More to be expected more than administering beginning day.
Key exclusion criteria
1.It a large amount is pericardial fluid with the subjective symptom is does pleural effusion or is a patient who admits as for the peritoneal fluid.
2.Patient with bone metastasis and brain metastasis focus where vena cava superior syndrome and pain are strong to need radiotherapy in emergency
3.It is a patient from whom the having infectious disease is doubted as for the patient and generation of heat that has the infectious disease.
4.It is a patient who has as for the syndrome of complication.
5.Patient who has clear tip neurological symptom (However, the one that originates in an original disease is excluded).
6.Patient who has the past of clear medicine hypersensitivity to treatment
7.Case from whom interstitial pneumonia or fibroid lung clear because of simple X rays of chest is admitted
8.Patient who has pregnant woman or possibility of pregnancy
Case who judged that physician in charge is improper to this treatment object
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yosida kazuo |
Organization
Shinshu University School of Medicine
Division name
Department of Respiratory organ surgery
Zip code
Address
Asahi 3-1-1,Matsumoto,Nagano,390-8621,Japan
TEL
0263-37-2657
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yosida kazuo |
Organization
Shinshu University School of Medicine
Division name
Department of Respiratory organ surgery
Zip code
Address
Matsumoto,Nagano,390-8621,Japan
TEL
0263-37-2657
Homepage URL
Sponsor or person
Institute
Nagano Prefecture lung cancer chemotherapy 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 | 12 | Month | 31 | 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
Date of protocol fixation
| 2005 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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
| 2005 | Year | 08 | Month | 31 | Day |
Last modified on
| 2005 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000147
