UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Title of the study (Brief title)	Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Region	Japan

Condition
Condition	Non-Small-Cell Lung Cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We confirmed the complete resection rate of Weekly nab-Paclitaxel / CBDCA + radiation therapy combination therapy as a preoperative introduction therapy for Stage IIIA and III B non-small cell lung cancer, and as secondary endopoint, 2 years no relapse survival rate, Evaluate progression free survival rate for 2 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The complete resection rate
Key secondary outcomes	2 years no relapse survival rate and progression free survival rate for 2 years.

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	Weekly nab-Paclitaxel+Carboplatin with Radiotherapy
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathological stage IIIA, IIIB stage that is diagnosed as pathologically non-small cell lung cancer and judged to be resectable on the image. 2) Diagnosis of ipsilateral mediastinal lymph node metastasis (N2) is histologically proven (bronchoscopy, mediastinoscopy), or obvious swelling (minor diameter greater than 20 mm) allowed . 3) For T4, a case clearly showing invasion on the image (CT, MRI, PET - CT). 4) Cases with no resistance to chemotherapy or radiotherapy for non-small cell lung cancer 5) ECOG's Performance Status (PS) is 0 to 1. 6) The age is over 20 years old and under 79 years old. 7) Within 14 days prior to enrollment patients have adequate bone marrow, liver, kidney and lung function
Key exclusion criteria	1) Taxane and CBDCA are contraindicated for administration. 2) A history of severe drug sensitivity. 3) A history of hypersensitivity to albumin. 4)Interstitial pneumonia or pulmonary fibrosis apparent in chest radiography. 5) Active or duplicated cancer with metachronous or simultaneous, multiple cancers. 6) Pleural effusion, drainage and pericardial effusion required drainage. 7) Have serious complications. 8) Patients with peripheral neuropathy of Grade 2 or higher. 9) HBs antigen positive 10) Pregnant women or women who may be pregnant. 11) A man who is willing to conceive. 12) The doctor in charge judged unsuitable for registration of this exam.
Target sample size	25

Research contact person
Name of lead principal investigator	Masato Sasaki
Organization	University of Fukui Faculty of Medical Sciences
Division name	Division of Thoracic Surgery, Department of Surgery
Address	23-3 Matsuoka- Shimoaizuki, Eiheiji, Fukui 910-1193, Japan
TEL	0776-61-3111
Email	masato@u-fukui.ac.jp

Public contact
Name of contact person	Masato Sasaki
Organization	University of Fukui Faculty of Medical Sciences
Division name	Division of Thoracic Surgery, Department of Surgery
Address	23-3 Matsuoka- Shimoaizuki, Eiheiji, Fukui 910-1193, Japan
TEL	0776-61-3111
Homepage URL
Email	masato@u-fukui.ac.jp

Sponsor
Institute	University of Fukui Faculty of Medical Sciences
Institute
Department

Funding Source
Organization	University of Fukui Faculty of Medical Sciences
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 01 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035413