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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031017
Receipt No. R000035413
Scientific Title Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2019/01/24
Last modified on 2018/01/26

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Basic information
Public title Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Acronym Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Scientific Title Weekly nab-Paclitaxel+Carboplatin with Radiotherapy as First Line Therapy in Patients with Advanced Non-Small-Cell Lung Cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Masato Sasaki
Organization University of Fukui Faculty of
Medical Sciences
Division name Division of Thoracic Surgery, Department of Surgery
Zip code
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
1st name
Middle name
Last name Masato Sasaki
Organization University of Fukui Faculty of Medical Sciences
Division name Division of Thoracic Surgery, Department of Surgery
Zip code
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)

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
2019 Year 01 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 Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
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

Other
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

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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