UMIN-CTR Clinical Trial

Public title

Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)

Acronym

Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)

Scientific Title

Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)

Scientific Title:Acronym

Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Weekly Paclitaxel, Carboplatin and Bevacizumab in patients with 70 years or older non-squamous NSCLC.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Safety, Disease control rate, Progression free survival, Overall survival, Biomarker analysis, correlation of efficacy with EGFR gene mutation

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

Bevacizumab, Paclitaxel, Carboplatin

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) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology
2) No prior chemotherapy
3) 70 years or older
4) ECOG-PS 0 or 1
5) At least one or more measurable lesion by RECIST.
6) Adequate organ function
7) Interval
-Palliative radiotherapy >2wks
-Surgery >4wks
-thoracic drainage>1wks
-biopsy with dissection, indwelling port >1wks
-blood transfusion >1wks
8) Life expectancy more than three months.
9) Written Informed Consent

Key exclusion criteria

1) History of hemoptysis
2) High risk of bleeding or thrombus events
3) History of anticoagulant within 10 days before enrollment
4) Grade 2 or worse neuropathy
5) Uncontrollable hypertension
6) Symptomatic brain metastasis
7) Uncontrollable pleural effusion or peritoneal effusion
8) Scheduled operation
9) Severe complications
10) Severe infection
11) History of active double cancer
12) No intention to birth control
13) Unstable psychic disorder
14) History of treatment drug
15) History of severe allergic reaction with platinum drug or monoclonal antibody
16) History of allergic reaction with taxan drug, polyoxyethylene or alcohol.
17) Decision of ineligibility by a physician.

Target sample size

36

Name of lead principal investigator

1st name
Middle name
Last name	HIrohisa Yoshizawa

Organization

Niigata University Medical & Dental Hospital

Division name

Bioscience Medical Research Center

Zip code

Address

1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan

TEL

025-227-2517

Email

hy0522@med.niigata-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Satoru Miura

Organization

Niigata University Medical & Dental Hospital

Division name

Division of Respiratory Medicine

Zip code

Address

1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan

TEL

025-227-2200

Homepage URL

Email

miusat1118@med.niigata-u.ac.jp

Institute

North East Japan Study Group

Institute

Department

Personal name

Organization

North East Japan Study Group

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

2011

Year

10

Month

28

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28150074

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

2011

Year

09

Month

07

Day

Date of IRB

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2015

Year

06

Month

12

Day

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

27

Day

Last modified on

2017

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007826