UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023802 |
|---|---|
| Receipt number | 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 00:31:22 |
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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
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
xyghx335@gmail.com
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027425
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