UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012025 |
|---|---|
| Receipt number | R000014005 |
| Scientific Title | Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2019/10/19 09:11:08 |
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Basic information
Public title
Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer
Acronym
Phase 2 study of CBDCA and weekly nab-PTX for elderly squamous cell lung cancer
Scientific Title
Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer
Scientific Title:Acronym
Phase 2 study of CBDCA and weekly nab-PTX for elderly squamous cell lung cancer
Region
| Japan |
Condition
Condition
squamous cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate for efficacy and toxicities of CBDCA and weekly nab-PTX for elderly(more than 75 years-old) squamous cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
overall survival,response rate,toxicities,disease control rate
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
CBDCA at the dose of area under curve 5 (day1) and nab-PTX at the dose of 100mg/m2(day1.8.15)every 3 weeks ,up to 6 cycles.
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)Definitively diagnosed with having squamous cell lung cancer by the specimens histologically or cytologically.
2)Clinical Stage 3B which curative radiotherapy is not indicated,4 or postoperative recurrence.
3)No prior chemotherapy.
*Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted.
4)No prior radiotherapy for primary lesions.(Palliative local radiation except for primary lesion is permitted.)
5)At least one measurable lesion.
6)Age of 75 year or older.
7)ECOG Performance status of 0-1.
8)Sufficient major organ function as below
*Neutrophil count>=1500/mm3
*Platelet count>=100000/mm3
*Hemoglobin>=9.0g/dl
*total bilirubin<=1.5mg/dl
*AST<=ULNX2.5
*ALT<=ULNX2.5
*Serum creatinine<=1.5mg/dl
*PaO2>=60 Torr or more(or SpO2 >=95% or more)
9)Life expectancy of at least 3months
10)Written informed consent
Key exclusion criteria
1)With active other organ cancer
2)With active infection
3)With fever equal to or more than 38C
4)With mental disorder
5)With symptomatic brain metastasis
6)Pleural and peritoneal effusion likely to require surgical intervention,or pericardial effusion
7) Systematic steroids , immunosuppressive medication or poorly controlled diabetes
8)Grade 2 or higher peripheral neuropathy
9)Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
10)poorly controlled hypertension
11)Ischemic heart disease or cardiac infarction within 6 months before enrollment
12)History of severe drug allergies
13)Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kudoh,Sinzoh |
| Middle name | |
| Last name | Kudoh,Sinzoh |
Organization
Osaka City University Hospital
Division name
Department of Pulmonary Medicine
Zip code
5458586
Address
1-5-7 Asahi-machi,Abeno-ku,Osaka-shi,545-8586,Osaka,Japan
TEL
06-6645-2121
shinzohykudoh@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushima,Utae |
| Middle name | |
| Last name | Katsushima,Utae |
Organization
Osaka City General Hospital
Division name
Department of clinical oncology
Zip code
5340021
Address
x9i \[/
TEL
06-6929-1221
Homepage URL
u_sota123@yahoo.co.jp
Sponsor or person
Institute
Osaka City General 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
Osaka City General Hospital
Address
2-13-22,Hondori,Miyakojima,Miyakojima-ku,Osaka-shi,534-0021,Osaka,Japan
Tel
06-6929-1221
u_sota123@yahoo.co.jp
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
大阪市立大学
大阪市立総合医療センター
近畿中央胸部疾患センター
淀川キリスト病院
ベルランド総合病院
JR大阪鉄道病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 11 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014005
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