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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004118
Receipt No. R000004951
Scientific Title A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2010/08/27
Last modified on 2013/09/27

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Basic information
Public title A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer
Acronym A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Non-Small-Cell Lung Cancer
Scientific Title A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Non-Small-Cell Lung Cancer
Region
Japan

Condition
Condition non-squamous non-small-cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of bevacizumab combined with Cisplatin and Pemetrexed for patients with advanced non-squamous non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes STEP1
Safety
STEP2
Overall Response Rate
Key secondary outcomes Progression-free survival (PFS)
Overall Survival
Overall Response Rate for combination CT
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 Cislpatin (75mg/m2 day1) + Pemetrexed(500mg/m2 day1) + Bevacizumb (15mg/kg day1) q3weeks 4(-6)cycles followed by Bevacizumab (15mg/kg day1)q3weeks 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer
2) Stage III/IV without indication for curative resection and post-operative recurrent disease
3) Patients aged 20-74 years
4) ECOG performance status 0-1
5) Target lesion is measurable(RECISTver1.1)
6) Chemotherapy naive
7) Excepted to live over 3 months after administration day
8) More than 2 months rest period after radiation
9) Adequate organ function
10) Written informed consent from the patients
Key exclusion criteria 1) squamous cell carcinoma
2) Patients unable to take or unsupplied with folic acid and vitamin B12
3) History of grave drug allergic react
4) current or previous histoty of hemoptysis (2.5ml) due to NSCLC
5) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
6) Brain metastases with neurological symptoms
7) Pleural effusion, pericardial effusion and ascites to need treatment
8) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
9) Uncontrollable diabetes mellitus and hypertenson
10) severe cardiac disease
11) Current or previous history of cerebrovascular disease
12) Current of amalgamated venous thromboembolism
13) Uncontrollable infectious disease
14) current or previous (within the last 1 year) history of GI perforation
15) Traumatic fracture of unrecovery
16) active concomitant malignancy
17) Thoracic radiotherapy has been scheduled for the examination period
18) Surgical procedure within 28 days before registration
19) history of pregnancy or lactation
20) No intention to practice birth control
21) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhito Funai
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL 053-435-2276
Email kfunai@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazuhito Funai
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL 053-435-2276
Homepage URL
Email kfunai@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, First Department of Surgery
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine, First Department of Surgery
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 浜松医科大学(静岡県)、県西部浜松医療センター(静岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 27 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
2010 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 08 Month 27 Day
Last modified on
2013 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004951

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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