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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006912
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hokuriku Thoracic Oncology Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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