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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014740
Receipt No. R000017132
Scientific Title Phase 2 study of efficacy and safety of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with newly diagnostic brain metastatisis stage IV non-sq NSCLC
Date of disclosure of the study information 2014/09/01
Last modified on 2015/02/04

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Basic information
Public title Phase 2 study of efficacy and safety of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with newly diagnostic brain metastatisis stage IV non-sq NSCLC
Acronym Phase 2 study of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with brain metastatisis stage IV non-sq NSCLC
Scientific Title Phase 2 study of efficacy and safety of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with newly diagnostic brain metastatisis stage IV non-sq NSCLC
Scientific Title:Acronym Phase 2 study of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with brain metastatisis stage IV non-sq NSCLC
Region
Japan

Condition
Condition newly diagnostic brain metastatisis stage IV non-sq NSCLC
Classification by specialty
Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examination efficacy and safety of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with newly diagnostic brain metastatisis stage IV non-sq NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Intracranial Progression-free Survival ( iPFS)
Key secondary outcomes Intracranial Objective Response Rate (iORR), Overall Response Rate (ORR), Progression-free Survival (PFS), Overall Survival (OS), maximal reduction ratio of brain metastasis, efficacy and safety according to EGFR mutation status

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 Maneuver
Interventions/Control_1 concurrent WBRT with erlotinib
WBRT 30 Gy / 10fxs / 2 weeks or
37.5 Gy / 15fxs / 3weeks
erlotinib 150 mg/day, day 1-14
followed by erlotinib plus bevacizumab
erlotinib 150 mg/day, everyday medication
bevacizumab 15 mg / kg, day 1, tri-weekly
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 diagnosed non-sq NSCLC patients
2) Patients with brain metastases confirmed by MRI
3) The presence of measureable brain metastasis by RECIST
4) Age moer than 20 and less than 80 years old
5) Performance status 0-2 (ECOG)
6) Adequate organ function
WBC more than 3000/mm3
Neutrophil more than 1500/mm3
Platelet more than 75000/mm3
Hemoglobin more than 9.0 g/dL
AST, ALT less than 2.5 times of the upper limits of normal level
Total bilirubin less than 1.5 mg/dL
Creatinine less than 1.2 mg/dL
SpO2(Room air) more than 93%
Proteinuria less than 2+
7) Interval
Palliative radiotherapy (exclude chest) >= 2weeks
Surgery >= 8weeks
Chest drainage>= 2weeks
8) Life expectancy more than 3 months
9) Written informed consent to participate
Key exclusion criteria 1) Current history of hemosputum within one month
2) Past given the radiation therapy for chest
3) Symptomatic meningeal dissemination
4) Patients who have previously treated with EGFR TKI within 6 months
5) Obvious interstitial pneumonia , fibroid lung confirmed by chest X-ray
6) Patients unable to be treated with oral medication
7) Therapeutic anticoagulation; regular use of aspirin (>325 mg/day)
8) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis
9) Infectious disease that required systemic therapy
10) Fever over 38
11) Uncontrolled pleural effusion, ascites, or pericardial effusion
12) Active synchronous malignant neoplasm
13) History of drug allergy that may influenced with this treatment
14) Severe GI disease
15) Suspected of other severe clinical conditions or abnormal laboratory values
16) Uncontrolled psychotic disease
17) Pregnant, Lactating or possibility of pregnancy
18) Patients who were judged inappropriate to entry this study by physician
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonobu Koizumi
Organization Shinshu University Hospital
Division name Comprehensive Cancer Center
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2554
Email tomonobu@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Sasaki
Organization Shinshu University Hospital
Division name Comprehensive Cancer Center
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2554
Homepage URL
Email s_sasaki@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital, Comprehensive Cancer Center
Institute
Department

Funding Source
Organization Shinshu University Hospital
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
2014 Year 09 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
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 Preinitiation
Date of protocol fixation
2014 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 09 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
2014 Year 08 Month 01 Day
Last modified on
2015 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017132

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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