UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000006809
Receipt number	R000007916
Scientific Title	Phase II Study of Paclitaxel and Carboplatin plus Bevacizumab in StageIIIA-N2, IIIB, IV patients with Nonsquamous Non-Small-Cell Lung Cancer
Date of disclosure of the study information	2011/12/01
Last modified on	2020/06/07 09:25:40

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Basic information

Public title

Phase II Study of Paclitaxel and Carboplatin plus Bevacizumab in StageIIIA-N2, IIIB, IV patients with Nonsquamous Non-Small-Cell Lung Cancer

Acronym

Phase II Study of PTX and CBDCA plus Bevacizumab for Nonsquamous NSCLC

Scientific Title

Phase II Study of Paclitaxel and Carboplatin plus Bevacizumab in StageIIIA-N2, IIIB, IV patients with Nonsquamous Non-Small-Cell Lung Cancer

Scientific Title:Acronym

Phase II Study of PTX and CBDCA plus Bevacizumab for Nonsquamous NSCLC

Region

Japan

Condition

chemotherapy-naïve StageIIIA-N2, IIIB, IV patients with nonsquamous non-small-cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

Evaluation of the efficacy and safety of Paclitaxel, Carboplatin, and Bevacizumab in chemotherapy-naïve StageIIIA-N2, IIIB, IV patients with nonsquamous non-small-cell lung cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Endothelial progenitor cells as biomarker
Safety
Maximum reduction rate of primary tumor size
Resectability rate as induction therapy
Progression Free survival
Over all survival

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CBDCA AUC=5(day1)+
Paclitaxel 200mg/m 2 (day1)+
Bevacizumab 15mg/kg (day1)
q3weeks 2-6cycles

Patients who get efficacy above SD without unacceptable toxity, then continuously are treated with Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, until disease
progression.

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

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed non-squamous non-small-cell lung cancer
2)Stage IIIA-N2(multipule,bulky)/IIIB/IV without indication for curative radiation therapy
3)No prior systemic treatment advanced NSCLC
4)Performance Status(ECOG) 0-1
5)Patient who has at least one or more measurable lesion by RECIST
6)Patients aged 20 years or older
7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following
criteria
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST and ALT, x 2.5 of upper limit of
normal (ULN) or less.
*Total bilirubin <=1.5mg/dL.
*Serum creatinin, x 1.5 of ULN or less.
*Electrocardiogram Nomal
*SpO2 >=90% or SaPO2 >=65mmHg
*Protein urea >= 1+
8)Patients who are considered to
survive for more than 3 months.
9)interval:
(1) Radiation therapy
*More than 2 weeks after the last irradiation to other organs.
(2)Operation (including pleurodesis)
*More than 4 weeks after the operation without Lobectomy (including exploratory surgery)
*More than 2 weeks after the last operation (including pleurodesis)
10)Patients providing written informed consent

Key exclusion criteria

1) Radiation therapy(expect chest)
2)Patients with untreated Brain metastases
3)Patients with current or previous history of hemoptysis (2.5mL or more)
4)Patients with uncontrolled hypertension
5)Patients with uncontrolled infection
6)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis
7)Patients with uncontrollable complications
8)Patients with massive pleural or pericardial effusion,or ascites
9)Patients with active concomitant malignancy
10)Patients with previous histories of drug allergy
11)Patients with uncontrollable gastrointestinal ulceration
12)Patients with current or previous (within one year) history of gastrointestinal perforation
13)Patients with therapeutic anticoagulopathy (including Aspirin
over 325mg/day)
14)Pregnancy or lactation
15)Inappropriate patients for this study judged by the physicians

Target sample size

Research contact person

Name of lead principal investigator

1st name Yoshihiro

Middle name

Last name Minamiya

Organization

Akita University Graduate School of Medicine

Division name

Department of Chest, Breast and Endocrinologic Surgery

Zip code

0108543

Address

1-1-1 Hondo, Akita, Japan

TEL

018-884-6132

Email

minamiya@med.akita-u.ac.jp

Public contact

Name of contact person

1st name Kazuhiro

Middle name

Last name Imai

Organization

Akita University Graduate School of Medicine

Division name

Department of Chest, Breast and Endocrinologic Surgery

Zip code

0108543

Address

1-1-1 Hondo, Akita, Japan

TEL

018-884-6132

Homepage URL

Email

i-karo@mui.biglobe.ne.jp

Sponsor or person

Institute

Akita University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Akita University School of Medicine/ Department of Integrated Medicine, Department of Internal Medicine Division of Cardiovascular and Respiratory Medicine

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Akita University School of Medicine/

Address

1-1-1 Hondo, Akita, Japan

Tel

018-884-6132

Email

nintei@hos.akita-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

秋田赤十字病院呼吸器外科(秋田県)、秋田組合総合病院呼吸器内科呼吸器外科
(秋田県)、中通総合病院呼吸器外科(秋田県)、由利組合総合病院呼吸器内科呼
吸器外科(秋田県)、仙北組合総合病院呼吸器外科(秋田県)、山本組合病院呼吸器
内科(秋田県)、能代山本医師会呼吸器外科(秋田県)、市立秋田総合病院呼吸器内
科(秋田県)、雄勝中央病院外科(秋田県)、八戸市立市民病院呼吸器外科(青森県)、
山形県立新庄病院外科(山形県)

Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 01 Day

Related information

URL releasing protocol

Publication of results

Unpublished

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

2011 Year 12 Month 01 Day

Date of IRB

2011 Year 10 Month 25 Day

Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2011 Year 12 Month 01 Day

Last modified on

2020 Year 06 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007916