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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008158
Receipt No. R000009603
Scientific Title A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Date of disclosure of the study information 2012/07/01
Last modified on 2018/12/18

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Basic information
Public title A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Acronym A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Scientific Title A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Scientific Title:Acronym A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Region
Japan

Condition
Condition Previously treated non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Bevacizumab plus oral S1 previously treated 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 Response rate
Key secondary outcomes Progression-free survival, Overall survival, Frequency and grade of adverse event

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 Bevacizumab 15mg/kg (day1, 22) + S-1 80mg/m2 (day1~14) 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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer
2.Stage III/IV non-small cell lung cancer without any indications for radiotherapy
3.Measurable disease
4.Patients who have previously treated with one regimen
5.EGFR, ALK, and MET inhibitor mono-therapy or combination therapy does not mean previous chemotherapy regimen
6.Adjuvant chemotherapy and Neo-adjuvant chemotherapy is not included in a postoperative regimen
/ at least 180 days interval from the last dosage of adjuvant chemotherapy
7.Age 20=<
8.ECOG performance status of 0 to 2
9.Patiants who can take in drug orally
10.Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 3,500 /mm3
Neu >= 1,500 /mm3
Plt >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
AST (GOT) , ALT (GPT) =< 100 IU/L
T. bil =< 1.5 mg/dL
Cr >= 1.5mg/dL
SpO2 >= 90% or >= 60 torr
11.Expected to live over 12 weeks after administration days
12.Written informed consent from the patients.
Key exclusion criteria 1.Adjuvant chemotherapy
2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia.
3.History of severe drug allergy
4.Active synchronous malignancies
5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
6.Severe complication
7.Metastasis to CNS
8.Patients with chest radiation treatment is required to reach the lung irradiation
9.Treated by flucytosine (5-FC)
10.Symptomatic brain metastasis
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 2-15 Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3833
Email tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 2-15 Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3833
Homepage URL http://www.med.osaka-u.ac.jp/pub/imed3/lab_8/clinical.html
Email tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute Dept. of Respiratory Medicine,
Osaka University Hospital
Institute
Department

Funding Source
Organization Dept. of Respiratory Medicine,
Osaka University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor OSAKA-LCSG
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 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Thirty patients were enrolled. The RR was 6.7% (95%CI 1.8-21.3%), and the disease control rate was 80% (95%CI 62.7-90.5%). Median PFS was 4.8 months (95%CI 2.7-6.4 months), and median OS was 13.8 months (95%CI 8.4 months-not applicable). Patients did not experience any Grade 4 toxicity or treatment-related death. Grade 3 hematologic toxicity (anemia) occurred in one patient (3.3%). The main Grade 3 non-hematologic toxicities were anorexia (10%), infection (10%), and diarrhea (6.7%).
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 06 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 07 Month 15 Day
Date trial data considered complete
2016 Year 07 Month 15 Day
Date analysis concluded
2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 13 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009603

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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