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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007386
Receipt No. R000008701
Scientific Title A Multicenter phase II study of S-1 combined with bevacizumab after platinum-based chemotherapy in patients with advanved non-squamous non-small cell lung cancer
Date of disclosure of the study information 2012/02/27
Last modified on 2015/02/27

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Basic information
Public title A Multicenter phase II study of S-1 combined with bevacizumab after platinum-based chemotherapy in patients with advanved non-squamous non-small cell lung cancer
Acronym Phase II study of S-1 plus bevacizumab
Scientific Title A Multicenter phase II study of S-1 combined with bevacizumab after platinum-based chemotherapy in patients with advanved non-squamous non-small cell lung cancer
Scientific Title:Acronym Phase II study of S-1 plus bevacizumab
Region
Japan

Condition
Condition advanved non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of S-1+bebacizumab for non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy
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 safety, response rate, overall 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 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1
Bevacizumab
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)Written informed consent before initiation of study-related procedures.
(2)Patients suitable for inclusion in the study according to the opinion of the investigator.
(3)Histologically or cytologically confirmed non-squamous non-small cell lung cancer, stage IIIB or IV, previously treated with platinum-based chemotherapy as a first line treatment.
(4)Age: 20 years<=
(5)With one or more measurable disease based on RECIST
(6)Performance status (ECOG) : 0-2
(7)Adequate function of vital organs
(8)Expected survival over 3 months
Key exclusion criteria (1)Squamous cell carcinoma
(2)Previously untreated with platinum-based chemotherapy as a first line treatment
(3)Discontinued bevacizumab due to its toxicity during a first line treatment
(4)Severe complications
(5)Symptomatic brain metastasis
(6)Tumor cavitation
(7)History or complication of hemoptysis with 2.5mL per time or more
(8)Continuouis bloody phlegm more than 1 week. History or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent.
(9)Uncontrollable hypertension
(10)History of GI perforation
(11)Planning of surgery
(12)Active concomitant malignancy
(13)Severe drug allergy
(14)Pregnancy or lactation
(15)Severe psychological illness
(16)History of thoracic radiotherapy
(17)Systemic steroid treatment
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Yamada
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7560
Email kayamada@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Yamada
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7560
Homepage URL
Email kayamada@med.kurume-u.ac.jp

Sponsor
Institute Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization Kyushu Medical Center
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
2012 Year 02 Month 27 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 02 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 02 Month 27 Day
Last modified on
2015 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008701

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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