UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016730
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email katakami@fbri.org

Sponsor
Institute Foundation for Biomedical Research and Innovation
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.