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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005486
Receipt No. R000006510
Scientific Title A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer reviously treated with platinum based chemotherapy
Date of disclosure of the study information 2011/04/22
Last modified on 2011/04/26

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Basic information
Public title A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy
Acronym A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy
Scientific Title A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy
Scientific Title:Acronym A PhaseII Study of Bevacizumab in Combination with S-1 in Patients with Non-Squamous Non-Small-Cell Lung Cancer
reviously treated with platinum based chemotherapy
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 in combination with S-1 for patients previously treated with combining chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes progression free survival,time to treatment failur,overall survival,and safety

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 S-1: 40 mg/m2 twice daily(orally, day1 after dinner ; day15 after breakfast)
Bevacizumab: 15mg/kg day 1
The treatment is repeated every three weeks until disease progression or severe toxicity.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histologically proven non-squamous non-small cell lung cancer
(2) Written informed consent after the explanation of the content of the examination
(3) Age:20-74 years old
(4) ECOG performance status of 0-1
(5) Life expectancy more than 3 months
(6) Adequate organ functions
1.Neutrophil ->2,000 /mm3
2.Platelet -> 100,000 /mm3
3.Hemoglobin concentration -> 9.0 g/dl
4.Total bilirubin <- 1.5 mg/dl
5.AST or ALT <- 100IU/l
6.Cr <= 1.5 mg/dl
Key exclusion criteria (1) Previously untreated with platinum doublet
(2) transfusion or G-CSF within 2weeks prior to enrollment
(3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
(4) History of severe drug allergy
(5) History of active double cancer within 5 years
(6) History of active severe infections
(7) Patients who have fever of over 38 degrees
(8) Continuous administration of steroid drug
(9) Severe cardiac disease
(10) History of thromboembolism or severe pulmonary disease
(11) History of GI bleeding,ileus,GI ulceration
(12) massive pleural or pericardial effusion,ascites
(13) Symptomatic brain metastases
(14) Uncontrollable hypertension or diabetes mellitus
(15) Uncontrollable diarrhea
(16) Wound of unrecovery
(17) Traumatic fracture of unrecovery
(18) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day)
(19) History of pregnancy or lactation
(20) Evaluated to be ineligible by a physician for other reasons
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Iwamoto
Organization Hiroshima citizens hospital
Division name Department of Medical Oncology
Zip code
Address 7-35 Motomachi , Naka-ku, Hiroshima, 730-8518, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Iwamoto
Organization Hiroshima citizens hospital
Division name Department of Medical Oncology
Zip code
Address 7-35 Motomachi , Naka-ku, Hiroshima, 730-8518, Japan
TEL
Homepage URL
Email

Sponsor
Institute Hiroshima citizens hospital
Department of Medical Oncology
Institute
Department

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
2011 Year 04 Month 22 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
2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 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
2011 Year 04 Month 22 Day
Last modified on
2011 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006510

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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