UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009081 |
|---|---|
| Receipt number | R000010600 |
| Scientific Title | A cohort study of Pemetrexed plus Cisplatin Plus Bevacizumab in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer. |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2012/10/10 16:52:25 |
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Basic information
Public title
A cohort study of Pemetrexed plus Cisplatin Plus Bevacizumab in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Acronym
A cohort study of Pemetrexed plus Cisplatin Plus Bevacizumab in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Scientific Title
A cohort study of Pemetrexed plus Cisplatin Plus Bevacizumab in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Scientific Title:Acronym
A cohort study of Pemetrexed plus Cisplatin Plus Bevacizumab in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Region
| Japan |
Condition
Condition
Non-squamous 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 Pemetrexed plus Cisplatin plus Bevacizumab in patients with stage III/IV non-squamous non-small-cell and lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free Survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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-squamous non-small cell lung cancer.
2)>=20 years old
3)ECOG PS0-2
4)evaluable tumor sites
5)Written informed consent from the patients.
6)Patients who participate in the trial are judged to be appropriate by the attending doctor.
Key exclusion criteria
1)Patient to the appropriate section of the "contraindication ", "contraindications for coadministration" in the attached document bevacizumab, pemetrexed and cisplatin.
2)Have a serious complications.
3)Patients who participate 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 | Hiroshi Kimura |
Organization
Nara Medical University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
840,shiijyo-cho,kashihara-city,Nara
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasue Suzaki |
Organization
Nara Medical University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
840,shiijyo-cho,kashihara-city
TEL
Homepage URL
Sponsor or person
Institute
Nara Medical 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
| 2012 | Year | 10 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 28 | 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
Multicenter prospective cohort study
Management information
Registered date
| 2012 | Year | 10 | Month | 10 | Day |
Last modified on
| 2012 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010600
