UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008158 |
|---|---|
| Receipt number | 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 14:18:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Dept. of Respiratory Medicine,
Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
