UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020359 |
|---|---|
| Receipt number | R000023518 |
| Scientific Title | Phase I/II study of carboplatin and nab-paclitaxel and concurrent thoracic radiation for patients with Locally advanced NSCLC |
| Date of disclosure of the study information | 2015/12/26 |
| Last modified on | 2015/12/28 14:02:33 |
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Basic information
Public title
Phase I/II study of carboplatin and nab-paclitaxel and concurrent thoracic radiation for patients with Locally advanced NSCLC
Acronym
Phase I/II trial of CBDCA/Nab-PTX/TRT
Scientific Title
Phase I/II study of carboplatin and nab-paclitaxel and concurrent thoracic radiation for patients with Locally advanced NSCLC
Scientific Title:Acronym
Phase I/II trial of CBDCA/Nab-PTX/TRT
Region
| Japan |
Condition
Condition
Locally advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to evaluate the usefulness and safty of carboplatin plus nab-paclitaxel and concurrent thoracic radiation against patients with locally advanced NSCLC. We decide the MTD and RD in this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I:
Primary endpoint; MTD and RD
Phase II:
Primary endpoint; Response rate
at 1 month after initial chemotherapy
Key secondary outcomes
Phase I:
Secondary endpoint; safety, response rate
Phase II:
Secondary endpoint; overall survival, progression-free survival, safety
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
Nab-PTX and CBDCA are weekly administered as 1 cycle until 6 cycles. Concurrent thracic radiation therapy is performed from day 1 (2Gy/fr; 5 days/1 week) until amount of 60Gy.
Dose and schedule:
Nab-PTX Dose of each level Day1 (q1w)
CBDCA AUC 2 Day1 (q1w)
Radiation 2GyX5days/week (total: 60Gy)
Nab-PTX Dose of each levels:
Nab-PTX
Level 3 80 mg/m2
Level 2 60 mg/m2
Level 1 40 mg/m2
Level 0 30 mg/m2
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) pathologically confirmed NSCLC
2) locally advanced IIIA or IIIB NSCLC
3) Age 20-74 yrs
4) PS 0-1
5) Life survival > 3 months
6) Mesureable target lesion
7) No prior teatment such as chemotherapy or radiation therapy
8) Adequate organ function
9) Informed consent
Key exclusion criteria
1) Interstitial pneumonia or pulmonary fibrosis
2) Pleural effusion, cardiac effusion or ascites requring drainage
3) Active double cancers
4) Uncotrollable angiona pectorias, cardian infarction, haear failure, diabetes mellitus, hypertension and severe infection
5) symptomatic brain metastasis
6) pregnancy
7) Alleary against CBDCA or nab-PTX
8) Inappropriate patients in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Hospital
Division name
Respiratory medicine
Zip code
Address
Showa-machi, Meebashi, Gunma
TEL
027-220-7111
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kyoichi kaira |
Organization
Gunma University Hospital
Division name
TR center
Zip code
Address
Showa-machi, Meebashi, Gunma
TEL
027-220-8222
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
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
| 2015 | Year | 12 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2015 | Year | 12 | Month | 26 | Day |
Last modified on
| 2015 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023518
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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