UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006912 |
|---|---|
| Receipt number | R000008168 |
| Scientific Title | A Randomized Phase II Trial of Pemetrexed or Pemetrexed/Bevacizumab in the First-Line Treatment of Elderly Patients with Advanced Non-squamous Non-small Cell Lung Cancer |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/08/01 10:39:18 |
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Basic information
Public title
A Randomized Phase II Trial of Pemetrexed or Pemetrexed/Bevacizumab in the First-Line Treatment of Elderly Patients with Advanced Non-squamous Non-small Cell Lung Cancer
Acronym
A randomized phase II trial of pemetrexed or pemetrexed/bevacizumab in elderly NSCLC patients
Scientific Title
A Randomized Phase II Trial of Pemetrexed or Pemetrexed/Bevacizumab in the First-Line Treatment of Elderly Patients with Advanced Non-squamous Non-small Cell Lung Cancer
Scientific Title:Acronym
A randomized phase II trial of pemetrexed or pemetrexed/bevacizumab in elderly NSCLC patients
Region
| Japan |
Condition
Condition
Non-squamous Non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety in elderly patients with previously untreated nonsquamous non-small cell lung cancer treated with pemetrexed or pemetrexed/bevacizumab.
Primary endpoint: response rate
Secaondary endpoints: Progression-free survival, disease-control rate, overall survival, safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
Progression-free survival,
Disease-control rate
Overall survival
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pemterexed therapy
Interventions/Control_2
pemetrexed and bevacizumab combination therapy
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven non-sqamous non-small cell lung cancer
2) Stage IIIB, IV or recullence
3) Measurable lesion(s)
4) age >or= 70 years old
5) Ecog PS 0,1
6) adequate organ function
7) life expectancy > or = 12 weeks
8) Written informed concent
Key exclusion criteria
1)Interstitial pneumonia or pulmonary fibrosis on chest X-ray
2) brain metastasis
3) history of hemoptysis
4) history or complications of obvious diverticulitis
5) cavitary lesions 1cm or more
6) serious complications
7) pleural effusion, ascitis drainage is necessary for, and pericardial effusion
8) active multiple primary cancer
9) pregnancy, lactation, or, intention to pregnancy
10) a history of serious drug hypersensitivity
11) patients whom it is judged to have difficulty in participation in study because of psychosis or neurologic disease
12) The case that is judged to be inadequacy for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kasahara |
Organization
Hokuriku Thoracic Oncology Group
Division name
Office
Zip code
Address
Takara-machi, 13-1, Kanazawa, Ishikawa
TEL
076-265-2278
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sone |
Organization
Hokuriku Thoracic Oncology Group
Division name
Office
Zip code
Address
Takara-machi, 13-1, Kanazawa, Ishikawa
TEL
076-265-2273
Homepage URL
Sponsor or person
Institute
Hokuriku Thoracic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
金沢大学附属病院、厚生連高岡病院 金沢医療センター 石川県立中央病院 小松市民病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 01 | 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
patients are recruiting.
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2012 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008168
