UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016173 |
|---|---|
| Receipt number | R000018268 |
| Scientific Title | A phase 2 trial of weekly nab-paclitaxel for advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene in salvage setting |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2019/03/04 07:43:28 |
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Basic information
Public title
A phase 2 trial of weekly nab-paclitaxel for advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene in salvage setting
Acronym
NICE Salvage study
Scientific Title
A phase 2 trial of weekly nab-paclitaxel for advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene in salvage setting
Scientific Title:Acronym
NICE Salvage study
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of weekly nab-PTX therapy for advanced Non-small cell lung cancer patients in salvage setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Overall Survival, Response Rate, Adverse event, Quality of life, Difference in efficacy according to prior docetaxel therapy.
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
weekly nab-Paclitaxel therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically proven NSCLC
2)Stage IIIb or IV
3)no EGFR mutation (exon19 deletion or L858R in exon 21) nor ALK fusion gene
4)two or three previous chemotherapy
5)age>20
6)ECOG PS 0-2
7)adequate organ function
8)expected survival days>90
9)written informed consesnt
Key exclusion criteria
1)symptomatic brain metastasis
2)massive or uncontrolable pleural effusion
3)less than two weeks after palliative irradiation for bone metastases or the brain metastasis except the primary tumor
4)previous chemotherapy with paclitaxel or nab-paclitaxel
5)active concomitant malignancy
6)active infectious disease
7)severe comorbidity
8)history of severe drug allergy
9)continuous steroid therapy
10)phsychiatry disease
11)pregnant or lactating woman
12)HBs antigen positive
13)Peripheral neuropathy>CTCAE Grade2
14)interstitial pneumoia or active lung fibrosis on chest X-ray
15)Otherwise determined by the investigator to be unsuitable as a subject in this study
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshige Yoshioka |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Miwa1-1-1, Kurashiki, Okayama, Japan
TEL
086-422-0210
hirotin@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Niwa |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Miwa1-1-1, Kurashiki, Okayama, Japan
TEL
086-422-0210
Homepage URL
tn13545@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central Hospital
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
神奈川県立循環器呼吸器病センター（神奈川県）、岸和田市民病院（大阪府）、九州がんセンター（福岡県）、倉敷中央病院（岡山県）、久留米大学病院（福岡県）、神戸市立医療センター中央市民病院（兵庫県）、神戸市立医療センター西市民病院（兵庫県）、静岡県立静岡がんセンター（静岡県）、順天堂大学医学部付属順天堂病院（東京都）、名古屋医療センター（愛知県）、和歌山県立医科大学付属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 15 | 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
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018268
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