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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010324
Receipt No. R000012085
Scientific Title Phase II study of Carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer
Date of disclosure of the study information 2013/03/27
Last modified on 2015/09/27

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Basic information
Public title Phase II study of Carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer
Acronym CBDCA/ weekly nab-PTX for elderly NSCLC patients
Scientific Title Phase II study of Carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer
Scientific Title:Acronym CBDCA/ weekly nab-PTX for elderly NSCLC patients
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of Carboplatin plus nab-paclitaxel in elderly patients with non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response Rate
Key secondary outcomes

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-paclitaxel 75mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4weeks.
Carboplatin AUC 6 is administered by an infusion lasting 30-60 minutes on day 1 following to nab-paclitaxel every 4 weeks.
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) Histologically or cytologically confirmed non-small cell lung cancer.
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3) No prior chemotherapy
*Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted.
*Picibanil use for plural effusion is permitted.
*EGFR-TKI and ALK inhibitor use for each driver mutation is permitted.
4) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.)
5) At least one measurable lesion
6) Age of 75 years or older
7) ECOG Performance status of 0-1
8) Sufficient major organ function as bellow
*Neutrophil count >= 1,500 /mm3
*Platelet count >= 100,000 /mm3
*Hemoglobin >= 9.0 g/dL
*total bilirubin <= 1.5 mg/dL
*AST <= 100 IU/L
*ALT <= 100 IU/L
*Serum creatinine <= 1.5 mg/dL
*Creatinine clearance >= 40 mL/min
*PaO2 >= 60 Torr or more (or SpO2 >= 95% or more)
9) Life expectancy of at least 3 months
10) Written informed consent
Key exclusion criteria 1) Previous treatment with paclitaxel as adjuvant chemotherapy
2) Active double cancer
3) Symptomatic brain metastasis
4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
5) Grade 2 or higher peripheral neuropathy
6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
7) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes)
8) History of Severe drug allergies.
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
10) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University Hospital
Division name Clinical Research, Innovation and Education Center
Zip code
Address 1-1, Seiryomachi, Aobaku, Sendai
TEL +22-717-8539
Email akinoue@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eisaku Miyauchi
Organization Tohoku University Hospital
Division name Clinical Research, Innovation and Education Center
Zip code
Address 1-1, Seiryocho, Aobaku, Sendai
TEL +81-22-717-8539
Homepage URL
Email akinoue@idac.tohoku.ac.jp

Sponsor
Institute North Japan Lung Cancer Study Group
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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
2013 Year 03 Month 27 Day
Last modified on
2015 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012085

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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