UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016730 |
|---|---|
| Receipt number | R000019417 |
| Scientific Title | A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer |
| Date of disclosure of the study information | 2015/03/07 |
| Last modified on | 2015/10/13 10:32:07 |
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Basic information
Public title
A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer
Acronym
A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer
Scientific Title
A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer
Scientific Title:Acronym
A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer
Region
| Japan |
Condition
Condition
Locally Advanced Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended doses and assess the efficacy and safety of carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
phase I:determine the recommended dose
phase II:response rate
Key secondary outcomes
phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy,2year survival rate
phase II:safety, progression free survival, overall survival, completion rate of chemoradiotherapy,2year survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemoradiotherapy:
Combination of weekly carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for a total 60Gy at 2Gy/fraction/day 5times weekly for 30 times.
Consolidation therapy:
Combination of carboplatin plus nab-paclitaxel every 4 weeks for 2 cycles.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Cytologically or histologically confirmed non-small-cell lung cancer
2)Unresectable locally advanced non-small-cell lung cancer (stage III)
3)When radio-oncologist judged that the patients can tolerable for full dose irradiation
4)No prior chemotherapy and thoracic radiotherapy
5)At least one measurable lesion
6)Aged 75 or more
7)ECOG Performance status of 0-1
8)Sufficient major organ function
9)Written informed consent
Key exclusion criteria
1)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis
2)V20 exceed 35%
3)Patients with opposite hilar lymph nodes metastases, or massive pleural or pericardial effusion
4)Patients with active double cancer
5)Patients with serious disease condition (severe infections,diarrhea,ileus,poorly controlled diabetes,
unstable angina,cardiac infarction within 6 months before enrollment,severe heart failure, etc.)
6)Severe emphysema, chronic bronchitis, asthma
7)Postoperative relapse
8)History of drug-induced pneumonia or severe drug allergies
9)History of hypersensitivity to albumin preparations
10)Grade 2 or higher peripheral neuropathy
11)Patients with severe mental illness
12)HBs antigen positive, or HBV-DNA positive ( HBs antigen negative but HBs antibody or HBc antibody positive)
13)Unsuitable patients judged by the attending physician
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Integrated Oncology
Zip code
Address
2-2, Minatojima-minamimachi, Cho-ku, Kobe
TEL
078-304-5200
katakami@fbri.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Integrated Oncology
Zip code
Address
2-2, Minatojima-minamimachi, Cho-ku, Kobe
TEL
078-304-5200
Homepage URL
katakami@fbri.org
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
HANSHIN Oncology Group
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
大阪府立成人病センター呼吸器内科（大阪府）、先端医療センター総合腫瘍科（兵庫県）、兵庫県立がんセンター呼吸器内科（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 07 | 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
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | 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 | 03 | Month | 06 | Day |
Last modified on
| 2015 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019417
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