UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011714 |
|---|---|
| Receipt number | R000013695 |
| Scientific Title | PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer. |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2021/10/19 13:14:49 |
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Basic information
Public title
PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Acronym
PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Scientific Title
PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with non-small cell lung cancer.
Scientific Title:Acronym
PhaseII study of nab-paclitaxel for elderly patients for the recurrence or Stage IIIB/IV with 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 explore efficacy and safety of nab-paclitaxel therapy for elderly patients 75 years or older with recurrence or Stage IIIB/IV with non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival, response rate,
frequency and the degree of the adverse event,QOL
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
Nab-paclitaxel 100mg/m2 on day 1,8,15
Cycles are repeated every three weeks.
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 confirmed diagnosis of NSCLC.
2 Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3 No prior chemotherapy
Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted.
Picibanil use for plural effusion 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 years or older
7 ECOG Performance status of 0-1
8 Adequate organ function
9 Life expectancy of at least 3 months
10 Written informed consent
Key exclusion criteria
1)Active double cancer
2)Active infectious disease
in need of systemic administration of anti-bacterial drugs
3)Uncontrolled psychiatric disease
4)History of Severe drug allergies.
5)Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment.
6)The continuous case that receive it from head to foot of the steroid
7)Severe concurrent disease
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University Omori Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
kazutoshiisobe@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University Omori Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
kazutoshiisobe@aol.com
Sponsor or person
Institute
Toho University Omori Medical Center
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
| 2013 | Year | 09 | Month | 12 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | 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=R000013695
