UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009539 |
|---|---|
| Receipt number | R000010360 |
| Scientific Title | Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201) |
| Date of disclosure of the study information | 2012/12/13 |
| Last modified on | 2018/12/18 14:19:13 |
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Basic information
Public title
Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201)
Acronym
OSAKA-LCSG1201
Scientific Title
Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201)
Scientific Title:Acronym
OSAKA-LCSG1201
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Pemetrexed and Bevacizumab in plutinum unfit patients with untreated non-squamous NSCLC patients.
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, 1 year survival rate, 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
Pemetrexed
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)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 or surgery
(3) Patient who unfit platinum
(4)Age 20=<
(5)ECOG performance status of 0 to 2
(6)With one or more measurable disease based on RECIST
(7) Interval
-Immune therapy, Endocrine therapy
>3wks
-Palliative radiotherapy >2wks
-Surgery >4wks
-thoracic drainage>1wks
-biopsy with dissection, indwelling port >2wks
-blood transfusion >2wks
(8)Adequate organ function, evaluated within 14 days before enrollment as
Neu >= 1,500 /mm3
Plt >= 10.0 x 10000 /mm3
hemoglobin >= 9.0 g/dL
T-bil =< 1.5 mg/dL
AST (GOT) ,ALT (GPT) =< 100 IU/L
Cr >= 1.5mg/dL
Proteinuria <1+
SpO2 >= 90%
(9)Expected to live over 3 months after administration days.
(10)Written informed consent from the patients.
Key exclusion criteria
(1)Symptomatic brain metastasis
(2) Have another active malignancy
(3) Current or previous history of hemoptysis
(4) Evidence of tumor invading large vessel on imaging
(5) Evidence of tumor invading trachea or main bronchus on imaging
(6) Have received radiation therapy to lesions of lung
(7) Currently have or have a history of a cardiac effusion which requires treatment
(8) Brain infarction within 1 year
(9) Problematic infection
(10) Scheduled operation
(11) Active radiation pneumonitis or esophagitis
(13) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(14) Decision of ineligibility by a physician.
Target sample size
45
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 | Masayoshi Higashiguchi |
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
higashiguchi@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
OSAKA-LCSG
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
| 2012 | Year | 12 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | 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=R000010360
