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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005991
Receipt No. R000007089
Scientific Title A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Date of disclosure of the study information 2011/07/20
Last modified on 2011/07/17

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Basic information
Public title A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Acronym A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Scientific Title A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Scientific Title:Acronym A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed 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 (EGFR mutation status Negative)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the efficacy and safety of Pemetrexed plus Carboplat plus Bevacizumab in followed by maintenance Pemetrexed in patients with previously untreated 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 Phase II

Assessment
Primary outcomes RR: Response rate
Key secondary outcomes QOL: Quality of life
DCR: Disease control rate
PFS: Progression free Survival
OS: Overall survival
AE: Adverse events

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 Four cycles of Pemetrexed + Carboplatin + Bevacizumab followed by maintenance Pemetrexed until disease progression
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer.(EGFR mutation status negative).
2)Stage III/IV unresectable or unsuitable for radical irradiation Non-Squamous NSCLC.
3)No prior chemotherapy .
4)Measurable tumor sites
5)ECOG-PS of 0 or 1.
6)20years-old,more than 80years-old
7)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial.
8)Life expectancy more than 3 months.
9)No problem adequate organ function
10) Written informed consent from the patients.
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan.
2)Patients with active co-morbidities including severe conditions.
1.uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease.
2.uncontrollable diabetes, hypertension.
3.severe infection
4.paresis of intestine, illeus
5.Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum
6.Great vessel involvement
7.Melena
8.Receiving anticoagulant drug
9.Uncontrolled urinari protein
10.CongenitalbleedingdiathesisCoagulation abnormalities
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated.
4) Brain metastases with neurological symptoms.
5) Active double cancer.
6)Pregnancy, breast feeding and suspected pregnancy.
7)History of grave drug allergic reaction.
8) Psychiatric disorder.
9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutoshi Isobe
Organization Toho University Omori Medical Center
Division name respiratory medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan
TEL 03-3762-4151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazutoshi Isobe
Organization Toho University Omori Medical Center
Division name respiratory medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email kazutoshiisobe@aol.com

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Non
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
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 07 Month 20 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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 07 Month 17 Day
Last modified on
2011 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007089

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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