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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023802
Receipt No. R000027425
Scientific 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
Date of disclosure of the study information 2016/08/28
Last modified on 2019/02/16

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Basic information
Public 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
Acronym A Phase II Study of biweekly Carboplatin, nab-paclitaxel, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Sadatomo Tasaka
Organization Hirosaki University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Zaifu-cho 5, Hirosaki, 036-8562, Japan.
TEL 0172-33-5111
Email tasaka@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Tanaka
Organization Hirosaki University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
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)

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 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

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
2016 Year 07 Month 01 Day
Date of IRB
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

Other
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

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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