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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005763
Receipt No. 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

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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
Email 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
Email noriko.yanagitani@jfcr.or.jp

Sponsor
Institute Japanese Foundation for Cancer Research, the Cancer Institute Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006702

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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