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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034591
Receipt No. 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 2018/10/22

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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
Middle name
Last name Masaki Fujita
Organization Fukuoka University, Facutly of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 0928011011
Email mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumiyasu Igata
Organization Fukuoka University, Facutly of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 0928011011
Homepage URL
Email figata@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University, Facutly of Medicine,
Department of Respiratory Medicine
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
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
2018 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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