UMIN-CTR Clinical Trial

Public title

Phase II study of Carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer using MNA

Acronym

OSAKA-LCSG1305

Scientific Title

Phase II study of Carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer using MNA

Scientific Title:Acronym

OSAKA-LCSG1305

Region

Japan

Condition

Squamous cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Carboplatin plus nab-paclitaxel in elderly patients with squamous cell lung cancer using MNA.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Overall survival, Progression free survival, Disease control rate, SPARC expression and safety.

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 100mg/m2 on days 1, 8, 15 + Carboplatin AUC 6 on day 1 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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed squamous cell lung cancer.
2) Clinical Stage III which curative radiotherapy is not indicated, IV or postoperative recurrence
3) MNA-SF score >= 8
4) No prior chemotherapy
*Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted.
5) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.)
6) At least one measurable lesion
7) Age of 70 years or older
8) ECOG Performance status of 0-1
9) 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/ALT <= ULN*2.5
*Serum creatinine <= 1.5 mg/dL
*PaO2 >= 60 Torr or more (or SpO2 >= 95% or more)
10) Life expectancy of at least 3 months
11) 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

30

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Kijima

Organization

Osaka University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

2-15 Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3831

Email

tkijima@imed3.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takayuki Shiroyama

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Department of Thoracic Malignancy

Zip code

Address

3-7-1 Habikino Habikino city Osaka

TEL

072-957-2121

Homepage URL

Email

takayuki.s12@hotmail.co.jp

Institute

OSAKA-LCSG

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

10

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

07

Month

17

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

17

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

10

Month

16

Day

Last modified on

2017

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013161