UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of adjuvant chemotherapy with carboplatin and nab-paclitaxel for resected NSCLC
Acronym	Feasibility study of adjuvant chemotherapy with carboplatin and nab-paclitaxel for resected NSCLC
Scientific Title	Feasibility study of adjuvant chemotherapy with carboplatin and nab-paclitaxel for resected NSCLC
Scientific Title:Acronym	Feasibility study of adjuvant chemotherapy with carboplatin and nab-paclitaxel for resected NSCLC
Region	Japan

Condition
Condition	resected NSCLC(stage II - IIIB)
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate feasibility of adjuvant chemotherapy with carboplatin and nab-paclitaxel for resected NSCLC with staged II to IIIB.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	1.Chemotherapy compliance in the four cycles 2.2-years disease free survival

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(AUC 5, day1) plus nab-PTX(100mg/m2,day1,8,15) 4 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)The patient histologically proven as non-small cell lung cancer (2)The patient with p-staged II - IIIB that received segmentectomy, lobectomy, or bi-lobectomy (3) Performance Status is 0 - 1 (ECOG). (4) 20 years of age or older (5) The patient who does not receive any chemotherapy, radiotherapy, or immunotherapy prior to resection (6) The patient who preserves the main organ ( the bone marrow, liver, kidney and so on ) (7) The patient who can receive chemotherapy within 4 - 8 weeks after resection (8) The patient who gives written informed consent
Key exclusion criteria	(1)The patient with infection (2)The patient with fever (equal to or more than 38 C) (3)The patient with heavy complication (4)The patient with active double-cancer (5)The patient with uncontrolled pleural effuson (6)The patient with a motor-palsy or figure of peripheral-nerve-disease (7)The patient with drug hypersensitivity (8)The patient with common use of NSAIDs (9)The expectant mother, the woman who has a lactating-woman and the possibility of the pregnancy (10)The patient judged as unsuitable by the doctor
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Middle name Last name Motoko Tachihara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address	7-5-1, Kusunoki-Cho,Chuo-Ku, Kobe
TEL	078-382-5846
Email	mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Motoko Tachihara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address	7-5-1, Kusunoki-Cho,Chuo-Ku, Kobe
TEL	078-382-5846
Homepage URL
Email	mt0318@med.kobe-u.ac.jp

Sponsor
Institute	Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Respiratory surgery, Kobe University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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 08 Month 28 Day
Date of IRB	2013 Year 09 Month 26 Day
Anticipated trial start date	2013 Year 09 Month 27 Day
Last follow-up date	2018 Year 09 Month 30 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 30 Day
Last modified on	2019 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013609