UMIN-CTR Clinical Trial

Basic information
Public title	The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Acronym	The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Scientific Title	The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Scientific Title:Acronym	The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of nab-paclitaxel+Carboplatin as adjuvant chemotherapy in patients with completely resected stage IB-IIIA non-small cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Accomplishment of 4 course treatment
Key secondary outcomes	2yr RFS,OS,RDI,Safty

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 is administered by an infusion lasting 30 minutes on days 1, 8,15 every 4weeks. Carboplatin AUC 5 is administered by an infusion lasting 30-60 minutes on day 1 following to nab-paclitaxel every 4 weeks for 4 courses
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically determined non-small cell lung cancer Completely resected 2) Pathological stageIB, IIA, IIB, IIIA 3) at least lobectomy and LN dissection (ND2a) or Elective Lymph Node Dissection 4) Completely resected 5) Neither previous chemotherapy nor radiotherapy before operation 6) ECOG performance status 0 or 1 7) Aged 20-80 years old 8) days before enrollment *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *total bilirubin <or= 1.5 mg/dL *AST and ALT x 2.5 of upper limit of normal (ULN) or les *Serum creatinine <= 1.5 mg/dL 9) Normal electocardiogram 10) Patients are excepted to live at least 3 months 11) Possible to receive chemotherapy within 8 months after surgery 12) Written informed consent
Key exclusion criteria	1) Allergy for CBDCA/nab-paclitaxel 2) History of Severe drug allergies 3) Myocardial infarction within 6 months 4) Interstitial pneumonia or pulmonary fibrosis detectable on X ray 5)Severe concurrent disease (Ischemic heart disease requiring treatment,arrhythmia,cardiac infarction within 6months before enrollment,hepatic failure,hemorrhagic peptic ulcer,poorly controlled diabetes) 6) History of active double cancerwithin 5years prior to the study 7) HBV-positive patients 8) Patients who are pregnant,considering pregnancy oractaing 9) Other conditions not suitable forthis study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Morihito Okada
Organization	Hiroshima University
Division name	Surgical Oncology
Zip code
Address	1-2-3,Kasumi,Minami-ku, Hiroshima,Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Yoshihiro Miyata
Organization	Hiroshima University
Division name	Surgical Oncology
Zip code
Address	Minami-ku, Hiroshima,Japan
TEL
Homepage URL
Email

Sponsor
Institute	Hiroshima University
Institute
Department

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
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 09 Month 05 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 07 Month 01 Day
Date of IRB	2013 Year 10 Month 07 Day
Anticipated trial start date	2013 Year 09 Month 05 Day
Last follow-up date	2017 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	2013 Year 07 Month 30 Day
Last modified on	2020 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013259