UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Response Rate

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

North Japan Lung Cancer Study Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

03

Month

27

Day

URL releasing protocol

Publication of results

Published

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

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 related 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