UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010324
Receipt number 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 10:33:27

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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 or person

Institute

North Japan Lung Cancer Study Group

Institute

Department

Personal name



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

Value
https://center6.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