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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009476
Receipt No. 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

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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
Institute The Tokyo cooperative oncology group
Institute
Department

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
URL(English) https://upload.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


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