UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035401
Receipt number R000040337
Scientific Title AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer
Date of disclosure of the study information 2018/12/29
Last modified on 2018/12/29 12:25:06

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Basic information

Public title

AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

Acronym

Randomized phase 2 of CDDP and PEM or S-1 plus Bev

Scientific Title

AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

Scientific Title:Acronym

Randomized phase 2 of CDDP and PEM or S-1 plus Bev

Region

Japan


Condition

Condition

Advanced non-squamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We conducted a randomized phase II trial comparing first-line S-1 plus cisplatin with bevacizumab and pemetrexed plus cisplatin with bevacizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC), and comare the safety and efficacy both regimens.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

progression-free survival

Key secondary outcomes

overall survival, overal response rate, time to treatment failure, safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cisplatin+S-1+Bev

Interventions/Control_2

Cisplatin+PEM+Bev

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

Eligible patients were required to have: histologically and/or cytologically proven unresectable stage IIIB or IV non-squamous NSCLC; no previous chemotherapy or radiotherapy; a performance status (PS) of 0-1 on the Eastern Cooperative Oncology Group; an age between 20 years and 74 years; a life expectancy of 12 weeks or more; adequate bone marrow reserve (leukocyte count > 4000 mm-3, neutrophil count > 2000 mm-3, platelet count > 100000 mm-3, and hemoglobin > 10 g dL-1); normal liver function (total serum bilirubin < 1.5 mg dL-1, and aspartate transaminase (AST), alanine transaminase (ALT) less than twice the upper limit of the normal range), normal renal function (normal serum creatinine and blood urea nitrogen levels) and pulmonary function (PaO2 > 70 torr).

Signed informed consent

Key exclusion criteria

Patients were excluded if they had malignant pleural or pericardial effusion, active double cancer, a concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction in the previous 3 months, heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension, interstitial pneumonia or lung disease, infection or other diseases contraindicating chemotherapy or radiotherapy, pregnancy, or breast-feeding.

Judging of inappropriate condition for this study by physian

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyoichi Kaira

Organization

Gunma University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

3-39-15, showa-machi, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-7111

Email

kkaira1970@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kyoichi Kaira

Organization

Gunma University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

3-39-15, showa-machi, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-7111

Homepage URL


Email

kkaira1970@yahoo.co.jp


Sponsor or person

Institute

Gunma Hospital

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

2018 Year 12 Month 29 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

Open public recruiting

Date of protocol fixation

2017 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 30 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

2018 Year 12 Month 29 Day

Last modified on

2018 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name