UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of biweekly Carboplatin, nab-paclitaxel, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
Title of the study (Brief title)	A Phase II Study of biweekly Carboplatin, nab-paclitaxel, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
Region	Japan

Condition
Condition	locally advanced Non-small cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the effectiveness and safety of biweekly carboplatin, nab-paclitaxel, and concurrent thoracic radiation therapy for patients with local advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year survival rate
Key secondary outcomes	Response rate, Progression free survival, Over all survival, Adverse events

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	Combination of biweekly calboplatin:AUC=4 plus nab-paclitaxel(100mg/m)with concurrent thoracic radiotherapy 2Gy/day for 30 times
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patient with pathologically or cytologically proven non-small cell lung cancer 2) Patient with stage IIIA or IIIB desease 3) Patient who has not been previously treated for lung cancer, including chemotherapy, radiotherapy, and operation 4) V20 < 35% 5) Patient who has at least one or more measurable lesion 6) ECOG performance status (PS): 0-1 7) Patient aged 20-74 years old 8) Adequate organ function. 9) Patient who are considered to survive for more than 3 months. 10) Written informed consent.
Key exclusion criteria	1) T3N1 2) Superior vena cava syndrome. 3) Lymph node metastases of opposite side hilum, malignant pleuritis, malignant pericarditis, lymphangitis. 4) With active double cancer. 5) Active infection. 6) Other serious disease condition (idiopathic pulmonary fibrosis, interstitial lung disease, renal failure, liver failure, Cerebral Vascular Disorder, unstable angina, cardiac infarction, Myocardial Infarction, poorly controlled diabetes mellitus,etc). 7) Grade2< peripheral neuropathy. 8) Severe drug allergy. 9) Pregnancy or lactation. 10) Patient whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size	28

Research contact person
Name of lead principal investigator	Sadatomo Tasaka
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	Zaifu-cho 5, Hirosaki, 036-8562, Japan.
TEL	0172-33-5111
Email	tasaka@hirosaki-u.ac.jp

Public contact
Name of contact person	Hisashi Tanaka
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	Zaifu-cho 5, Hirosaki, 036-8562, Japan.
TEL	0172-33-5111
Homepage URL
Email	xyghx335@gmail.com

Sponsor
Institute	Hirosaki University
Institute
Department

Funding Source
Organization	Hirosaki University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	弘前大学病院（青森県），靑森県立中央病院（青森県）弘前中央病院（青森県），国立病院機構弘前病院（青森県） 八戸市立市民病院（青森県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 28 Day
Last modified on	2019 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027425