UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003487 |
|---|---|
| Receipt number | R000004220 |
| Scientific Title | Phase II study of cisplatin plus S-1 with bevacizumab as first-line therapy for stage III/IV nonsquamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2010/04/16 |
| Last modified on | 2012/04/04 13:35:03 |
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Basic information
Public title
Phase II study of cisplatin plus S-1 with bevacizumab
as first-line therapy for stage III/IV nonsquamous non-small-cell lung cancer
Acronym
Phase II study of CDDP+S-1+Bevacizumab for advanced nonsquamous non-small-cell lung cancer
Scientific Title
Phase II study of cisplatin plus S-1 with bevacizumab
as first-line therapy for stage III/IV nonsquamous non-small-cell lung cancer
Scientific Title:Acronym
Phase II study of CDDP+S-1+Bevacizumab for advanced nonsquamous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
non-small-cell lung cancer (nonsquamous 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 cisplatin plus S-1 with bevacitumab in patients with stage III/IV nonsquamous non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
overall survival, progression-free survival, time to treatment failure, 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
Cisplatin (60mg/m2) and bevacizumab (15mg/kg) is administered on day 1, and S-1 (80mg/m2/day) is administered from day 1 to day 14
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
Histologically and/or cytologically proven nonsquamous NSCLC; patients with unresectable stage IIIB or IV, no previous
chemotherapy or radiotherapy; a performance status
of 0-1 on the Eastern Cooperative Oncology Group;
adequate bone marrow reserve (leukocyte ≥4000/mm3,neutrophil≥2000/mm3, platelet ≥100,000/mm3,hemoglobin≥9g/dL; normal liver function (total serum
bilirubin≤1.5mg/dL, and aspartate transaminase (AST), alanine
transaminase (ALT) less than twice the upper limit of the normal
range) and normal renal function (creatinine clearance≥60mL/min);PaO2≥60 torr or SpO2≥90%; proteinuria≤+1, INR≤1.5; a life expectancy of 12 weeks or more;written
informed consent should be obtained from all patients.
Key exclusion criteria
squamous cell (adenosquamous cell) lung cancer; Patients with a history of serious drug allergy, hemoptysis, thrombosis, concomitant malignancy, central nervous system metastases, active infectious diseases or other serious medical problems;hemorrhagic
diathesis or coagulopathy; therapeutic
anticoagulation; regular use of aspirin (>325 mg
per day), nonsteroidal antiinflammatory agents,
or other agents known to inhibit platelet function;use of steroid or flucytosine;pregnancy
;
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Sunaga |
Organization
Gunma University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Sunaga |
Organization
Gunma University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
027-220-8123
Homepage URL
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
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
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
| 2010 | Year | 04 | Month | 16 | 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
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 04 | Month | 14 | Day |
Last modified on
| 2012 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004220
