UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014740 |
|---|---|
| Receipt number | 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 19:25:33 |
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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
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
s_sasaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital, Comprehensive Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017132
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