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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005391
Receipt No. R000006387
Scientific Title Bevacizumab treatment of intra-venous administration and diagnostic nuclear medicine for symptomatic radiation necrosis in the brain
Date of disclosure of the study information 2011/04/07
Last modified on 2013/12/25

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Basic information
Public title Bevacizumab treatment of intra-venous administration and diagnostic nuclear medicine for symptomatic radiation necrosis in the brain
Acronym Bevacizumab treatment for symptomatic radiation necrosis
Scientific Title Bevacizumab treatment of intra-venous administration and diagnostic nuclear medicine for symptomatic radiation necrosis in the brain
Scientific Title:Acronym Bevacizumab treatment for symptomatic radiation necrosis
Region
Japan

Condition
Condition Symptomatic radiation necrosis after radiotherapy for primary and metastatic brain tumors, and tumors of the adjacent tissues to the brain
Classification by specialty
Hematology and clinical oncology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will evaluate efficacy of bevacizumab treatment of intravenous administration against symptomatic radiation necrosis which is refractory to preexisting medical treatments including corticosteroids, anticoagulants, and vitamin E.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Peri-lesional edema is decreased by more than 30% or equal on MRI after bevacizumab treatment and this reduction has been maintained for 4 weeks.
Key secondary outcomes Safety of bevacizumab treatment;
The amount of corticosteroids used;
The improvement of patient's performance status after bevacizumab;
The recurrence rate of radiation necrosis within one year from bevacizumab treatment;
The improvement of enhanced area by contrast medium on MRI

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Bevacizumab of 5mg/kg is administered intravenously every other week (day 1, day 15, day 29, day 43, day 57, and day 71), 6 cycles in total. MRI is examined after 3 cycles. Then the rest of 3 cycles are performed if peri-lesional edema is not aggravated.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Radiation necrosis occurring 3 months after radiotherapy for primary and metastatic brain tumors, and tumors of the adjacent tissues to the brain;
Patients with symptomatic radiation necrosis;
A lesion was enhanced by contrast medium accompanying to peri-lesional edema on MRI;
Radiation necrosis is diagnosed with F-BPA-PET or C-MET-PET and tumor recurrence is denied;
With regard to F-BPA-PET, lesion/normal ratios of less than 2.0 and 2.5 were absolute and relative indications for bevacizumab treatment, respectively. With regard to C-MET-PET, L/N ratios of less than 1.25 and 1.8 were absolute and relative indications for bevacizumab treatment, respectively;
Karnofsky performance status more than 60% or equal;
Patients are refractory to medical treatments including corticosteroids, anticoagulants, and vitamin E;
Patients cannot undertake necrotomy because of lesions in the eloquent area or poor general status;
Adequate hematologic, hepatic, and renal function (absolute neutrophil count more than 1500mm3 or equal; platelet count more than 100000mm3 or equal; hemoglobin more than 9.5 g/dl or equal; GOT and GPT less than 2.5 folds; total bilirubin less than 2.0 mg/dl or equal; serum creatinine less than 1.2 mg/dl or equal; urine protein less than 1+ or equal; PT-INR more than 1.5 folds or equal or 1.5 to 2.5 when warfarinization);
Life expectancy greater than 3 months;
Able to provide written informed consent by patients or legally authorized representative;
In cases of radiation necrosis with metastatic brain tumors, no active lesion is systemically detected by PET or other radiographical examinations and values of tumor marker are within normal limit if they are examined.
Key exclusion criteria Patients are able to undertake necrotomy;
Intracranial tumors are active and recurrent (L/N ratio on F-BPA-PET is greater than 2.5, or L/N ration on C-MET-PET is greater than 1.8;
Patients require intravenous administration of antibiotics, antiviral drugs, and antifugal drugs for infection;
Febrile patients more than 38 degree Celsius of body temperature or equal;
Patients having severe comorbidities such as heart diseases, pulmonary fibrosis, interstitial pneumonia, hemorrhagic diathesis, uncontrollable hypertension or diabetes;
*Comorbidity or history of unstable angina and myocardiac infarction within 6 months
*Uncontrollable peptic ulcer
*Uncontrollable hypertension
*Unhealed advanced wound or fracture
*Comorbidity or history of gastrointestinal perforation and fistula, and abdominal abscess within 6 months
*Comorbidity or history of emoptysis and pulmonary hemorrhage greater than Grade 1
*Comorbidity or history of vascular diseases (venous and arterial thrombosis and embolism, aortic aneurysms) required interventions within 6 months
*Congestive heart failure more than NYHA class I
*Patients with a schedule of an operation during this study or patients having had an operation within 4 weeks;
Patients with hemorrhage (intracranial hemorrhage, gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis);
PT-INR is greater than 2.5 or unstable when warfarinization;
History of severe hypersensitivity or allergy to bevacizumab;
Pregnant patients, patients with a possibility of pregnancy, or patients breastfeeding;
Investigators judge patients who are inappropriate to include this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Neurosurgery
Zip code
Address 2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL +81-72-683-1221
Email neu070@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Neurosurgery
Zip code
Address 2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL +81-72-683-1221
Homepage URL http://www.osaka-med.ac.jp/deps/neu/
Email neu070@poh.osaka-med.ac.jp

Sponsor
Institute Department of Neurosurgery, Osaka Medical College
Institute
Department

Funding Source
Organization Department of Neurosurgery, Osaka Medical College
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都大学 大学院医学研究科 脳病態生理学講座 脳神経外科(京都府)
社会医療法人厚生会 木沢記念病院 脳神経外科(岐阜県)
筑波大学 放射線腫瘍科 (茨城県)
千葉県がんセンター 脳神経外科 (千葉県)
北海道大学 脳神経外科 (北海道)
都立駒込病院 脳神経外科 (東京都)
熊本大学 脳神経外科 (熊本県)
杏林大学医学部附属病院 脳神経外科 (東京都)
広島大学病院 脳神経外科 (広島県)
久留米大学 脳神経外科 (福岡県)
大分大学医学部附属病院 脳神経外科 (大分県)
国立がん研究センター中央病院 脳脊髄腫瘍科 (東京都)
東京大学医学部附属病院 脳神経外科 (東京都)
岩手医科大学 脳神経外科 (岩手県)
東北大学医学部附属病院 脳神経外科 (宮城県) 

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 07 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 No longer recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 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
2011 Year 04 Month 06 Day
Last modified on
2013 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006387

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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