UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009476
Receipt number R000011130
Scientific Title A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2013/02/01
Last modified on 2019/04/20 14:20:27

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Basic information

Public title

A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer

Acronym

A phase II study of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
(TCOG LC-1202)

Scientific Title

A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer

Scientific Title:Acronym

A phase II study of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancer
(TCOG LC-1202)

Region

Japan


Condition

Condition

non-squamous non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of bevacizumab combined with Cisplatin and S-1 advanced non-squamous non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression Free Survival

Key secondary outcomes

Response Rate
Overall Survival
Waterfall Plot Analysis
Safety Profile
Quality of Life


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

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumb (15mg/kg day1) + Cislpatin (65mg/m2 day1) + S-1(80mg/m2 day1-14)
q3weeks at a target 6cycles(at least 4cycles) followed by Bevacizumab (15mg/kg day1) + S-1(80mg/m2 alternate-day(Mon.Wed.Fri.Sun.))
q3weeks 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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Written IC
2.Patients aged 20-74 years
3.ECOG performance status 0-1
4.Excepted to live over 3 months after administration day
5.Histologically or cytologically confirmed non-squamous non-small-cell lung cancer
6.Stage III/IV or post-operative recurrent disease
7.No prior chemotherapy
8.Target lesion is measurable(RECISTver1.1)
9.Adequate organ function

Key exclusion criteria

1.Symptomatic brain metastases
2.history of active double cancer within 5 years
3.Current history of hemosputum or hemoptysis
4.Have possibly complication related to bleeding episode
5.Receiving anticoagulant drug (including Aspirin over 325mg/day)
6.Great vessel involvement
7.Have received radiation therapy to lesions of lung
8.Pleural effusion,peritoneal fluid, and pericardial fluid
9.Serious complications
10.Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year
11.Uncontrollable Hypertension
12.Interstitial pneumonia or pulmonary fibrosis detectable on X ray
13.Proven or suspected infections diseases
14.Watery diarrhea or Chronic constipation
15.Under treatment by flucytosine
16.Hypersensitivity of Protocol agents
17.History of pregnancy or lactation and no intention to practice birth control
18.Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

39


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaoru Kubota

Organization

Nippon Medical School Hospital

Division name

nternal Medicine, Division of Pulmonary Medicine, Division of Medical Oncology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan

TEL

03-3822-2131

Email

tcog-lc@tcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name TCOG LC OFFICE

Organization

The Tokyo cooperative oncology group

Division name

Clinical Study Promotion Agency

Zip code


Address

Toa-Bldg.4F, 2-1-18 Hamamatsu-cho Minato-ku Tokyo Japan

TEL

03-5401-5020

Homepage URL


Email

tcog-lc@tcog.jp


Sponsor or person

Institute

The Tokyo cooperative oncology group

Institute

Department

Personal name



Funding Source

Organization

The Tokyo cooperative oncology group

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

2013 Year 02 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

2012 Year 12 Month 12 Day

Date of IRB

2012 Year 12 Month 12 Day

Anticipated trial start date

2013 Year 01 Month 07 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 12 Month 04 Day

Last modified on

2019 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name