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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004686
Receipt No. R000005575
Scientific Title A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Date of disclosure of the study information 2010/12/08
Last modified on 2019/06/21

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Basic information
Public title A phase II study of Carboplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Acronym A phase II study of Carboplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Scientific Title A phase II study of Carboplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Scientific Title:Acronym A phase II study of Carboplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Region
Japan

Condition
Condition Non-small cell lung cancer(Non squamous)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the he response rate and feasibility of Carboplatin+Pemetrexed+Bevacizumab in patients with Gefitinib refractory 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 II

Assessment
Primary outcomes Response rate
Key secondary outcomes progression free survival, overall survival, time to response, safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carboplatin+Pemetrexed+Bevacizumab every 3 weeks. Responding patients receive Pemetrexed+Bevacizumab maintenance.
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-squamous NSCLC
2. Stage IIIB, VI or recurrent post operative patients
3. measurable disease
4. life expectancy of at least 3 months.
5. 20>=age >75 years
6. performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
7. adequate organ function
adequate bone marrow (neutrophil count > =1,500/mm3, hemoglobin concentration > =9.0g/dL, platelet count >= 100,000 /mL), kidney (creatinine>= Cr 60), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =institutional normal level x 2.5, total bilirubin< =institutional normal level x 1.5 ), SpO2> =93, Proteinuria< 2g
8. positive sensitizing EGFR mutations
Key exclusion criteria 1. Radiation therapy to primary cancer
2.Active infection or other serious conditions
3. Severe pleural effusion or uncontrollable pleural effusion
4.Symptomatic brain metastasis
5. Uncontrollable hypertension
6. Uncontrollable diabetes mellitus
7. Current or previous history of hemoptysis or hemosputum
8. Current or previous (within the last 1 year) history of GI perforation
9. Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
10.Tumor invasive to the chest large blood vessel.
11.Evidence of bleeding diathesis or coagulopathy
12.History of active double cancer
13.History of active psychological disease
14.History of pregnancy or lactation
15. Active concomitant malignancy
16. Active mental illness
17. Previous treatment with Carboplatin or Pemetrexed or Bevacizumab
18. History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris etc)
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Hirohisa
Middle name
Last name Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code 951-8510
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Email hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Hirohisa
Middle name
Last name Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code 951-8510
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Homepage URL
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization Niigata Foundation for the Promotion of Medicine
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 Niigata university Institutional review board
Address 1-757 Asahimachi-dori, Niigata-city, Japan
Tel 025-227-2439
Email shinki-center@adm.niigata-u.ac.jp

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 燕労災病院(新潟県)
厚生連長岡中央綜合病院(新潟県)
国立病院機構西新潟中央病院(新潟県)
済生会新潟第二病院(新潟県)
上越総合病院(新潟県)
新潟県立がんセンター(新潟県)
新潟県立吉田病院(新潟県)
新潟県立新発田病院(新潟県)
新潟県立中央病院(新潟県)
新潟市民病院(新潟県)
新潟大学医歯学総合病院(新潟県)
新潟労災病院(新潟県)
長岡赤十字病院(新潟県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 08 Day

Related information
URL releasing protocol NA
Publication of results Unpublished

Result
URL related to results and publications NA
Number of participants that the trial has enrolled 35
Results
NA
Results date posted
2019 Year 06 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NS
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 08 Month 25 Day
Date of IRB
2012 Year 08 Month 01 Day
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2015 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 08 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005575

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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