UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034591 |
|---|---|
| Receipt number | R000039427 |
| Scientific Title | Carboplatin + nab-Paclitaxel treatment for non-small lung cancer with malignant pleural effusion -phase II trial- |
| Date of disclosure of the study information | 2018/10/24 |
| Last modified on | 2020/04/23 14:17:39 |
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Basic information
Public title
Carboplatin + nab-Paclitaxel treatment for non-small lung cancer with malignant pleural effusion -phase II trial-
Acronym
Carboplatin + nab-Paclitaxel treatment for malignant pleural effusion
Scientific Title
Carboplatin + nab-Paclitaxel treatment for non-small lung cancer with malignant pleural effusion -phase II trial-
Scientific Title:Acronym
Carboplatin + nab-Paclitaxel treatment for malignant pleural effusion
Region
| Japan |
Condition
Condition
Non-small lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of Carboplatin + nab-Paclitaxel treatment for non-small lung cancer with malingnant pleural effusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Control rate for malignant pleural effusion
Key secondary outcomes
RR, PFS, OS
Safety, one-year survival rate
Time for increase of pleural effusion
Rate of patients who did not require pleurodesis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CBDCA + nab-Paclitaxel
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 proven non-small lung cancer
2) Histologically proven malignant effusion
3) Age over 20-years old
4) Performance status (ECOG) = 0-2
5) Never used of anti-cancer treatment except for either kinase treatment or immuno-check point inhibitor
6) Eligible for adjuvant or relapse after surgical treatment
7) Surgical treatment after 6 weeks
8) Adjuvant treatment after one-year
9) Adequate organ functions
10) Patients who have estimated life expectancy longer than 12 weeks
11) Written informed consent
Key exclusion criteria
1) Allergy for either nab-Paclitaxel or Paclitaxel
2) Severe complications such as intersitial pneumonia, CHF, CRF, liver damage, uncontrolled DM or HT
3) Symptomatic brain metastasis
4) Need for dainage
5) History of pleurodesis
6) Surgical treatment within 2 weeks
7) Active infection
8) Active multiple malignancy
9) Uncontrolled mental sympotoms
10) Pregnancy or pregnant possibiltiy
11) Administration of corticosteroids
12) Patients whom doctor consider ineligible
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Fujita |
Organization
Fukuoka University, Facutly of Medicine
Division name
Department of Respiratory Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
TEL
0928011011
mfujita@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiyasu |
| Middle name | |
| Last name | Igata |
Organization
Fukuoka University, Facutly of Medicine
Division name
Department of Respiratory Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
TEL
0928011011
Homepage URL
figata@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University, Facutly of Medicine,
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University, Facutly of Medicine,
Department of Respiratory Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University - Medical Ethics Review Board
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
Tel
0928011011
cawati@fukuoka-u.ac.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
福岡大学西新病院（福岡県）、福岡大学筑紫病院（福岡県）、福岡徳洲会病院（福岡県）、福西会病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 24 | 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
0
Results
Registration is not expected.
Results date posted
| 2020 | Year | 04 | Month | 23 | Day |
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2020 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039427
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