UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000135 |
|---|---|
| Receipt number | R000000200 |
| Scientific Title | A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer. |
| Date of disclosure of the study information | 2005/09/08 |
| Last modified on | 2018/10/03 13:59:17 |
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Basic information
Public title
A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Acronym
A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Scientific Title
A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Scientific Title:Acronym
A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy, toxicity, and survival of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate(according to RECIST criteria)
Key secondary outcomes
Median survival time, 1-year survival,
Adverse events, Time to Progression, Quality of Life
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
The treatment schedule included carboplatin AUC 4 on day 1, and gemcitabine 1000 mg/ m2 on days 1 and 8, every 3 weeks. (Below six courses more than three courses.)
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)Patients with histologic or cytologic confirmation of locally advanced or metastatic NSCLC
2)Received either no prior chemotherapy were eligible
3)Measurable lesions
4)Age ≥ 70;
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
6)Adequate organ function
7)Life expectancy for more than 3 months
8)Written informed consent
Key exclusion criteria
1)After thoracic irradiation
2)A case having severe infection and a serious complication
3)Requiring treatment pleural/ascites /pericardial effusion,
4)Interstitial pneumonia or active lung fibrosis on chest X-ray,
5)Symptomatic brain metastases
6)Double cancer
7)Others
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Institute of Biomedical Research and Innovation
Division name
Department of Translational Research Division of Integrated Oncology
Zip code
Address
2-2,Minatojima-Minamimachi,Chuo-ku,Kobe 650-0047 Japan
TEL
078-304-5200
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nishimura |
Organization
Kobe City General Hospital
Division name
Respiratory Medicine
Zip code
Address
4-6,Minatojima-Nakamachi,Chuo-ku,Kobe 650-0046 Japan
TEL
078-302-4321
Homepage URL
t-nishi@kcgh.gr.jp
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
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
| 2005 | Year | 09 | Month | 08 | 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
| 2004 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000200
