UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005763 |
|---|---|
| Receipt number | R000006702 |
| Scientific Title | A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2018/06/14 12:45:46 |
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Basic information
Public title
A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Acronym
A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Scientific Title
A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Scientific Title:Acronym
A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Region
| Japan |
Condition
Condition
Advanced Non-Small Cell (Non squamous cell) Lung Cance
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of Cisplatin Pemetrexed and Bevacizum in a phase II clinical study of patients with advanced non-small cell Lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORR
Key secondary outcomes
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
CDDP+PEM+BEV
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
1)Histologically or cytrologically confirmed diagnosis of NSCLC with a adeno or large cell carcinoma
2)No prior systemic treatment advanced NSCLC with documented Stage IIIB or Stage IV or recurrent disease
3)Tumors must have measurable disease by RECIST version 1.1
4)20 years of age or older to 75 years exclusive
5))ECOG performance status 0 or 1
6)No problem adequate organ function
Key exclusion criteria
1)Subjects with interstitial pneumonia or pulmonary fibrosis.
2)Uncontrolled Active infection
3)No other active malignancies
4)Concurrent use of steroid therapy
5)Subjects with symptomatic brain metastases.
6)have had or require continuous oral administration of hemostat/have had or require injectable administration of hemostat
7)Uncontrolled pleural.
8)Have received radiation therapy to lesions of lung
9)Have a bleeding diathesis
10)Uncontrolled hypertension
11)Any other reason that,in the opinion of the investugator precludes the subject from participating in the study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nishio |
Organization
Japanese Foundation for Cancer Research, the Cancer Institute Hospital
Division name
Thoracic Oncology Center
Zip code
Address
3-8-31,Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
mnishio@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Yanagitani |
Organization
anese Foundation for Cancer Research, the Cancer Institute Hospital
Division name
Thoracic Oncology Center
Zip code
Address
3-8-31,Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
noriko.yanagitani@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research, the Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Cancer Research, the Cancer Institute Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2011 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
| 2011 | Year | 06 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006702
