UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007386 |
|---|---|
| Receipt number | 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 09:34:18 |
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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
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
kayamada@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008701
