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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029144
Receipt No. R000033313
Scientific Title Phase II clinical trial on clinical efficacy and safety of combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis
Date of disclosure of the study information 2017/10/10
Last modified on 2017/09/14

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Basic information
Public title Phase II clinical trial on clinical efficacy and safety of combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis
Acronym Ava-boron for poor prognosis MG
Scientific Title Phase II clinical trial on clinical efficacy and safety of combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis
Scientific Title:Acronym Ava-boron for poor prognosis MG
Region
Japan

Condition
Condition Recurrent malignant glioma

Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. Clinical effect of combination therapy of boron neutron capture therapy (BNCT) and bevacizumab (BV) using nuclear reactor for patients with recurrent glioma with poor prognosis was compared with overall survival (OS) as indicator.
2. Study the clinical effectiveness and safety of combination therapy of BNCT and BV with progression free survival (PFS) according to RANO (the Response Assessment in Neuro Oncology) and the occurrence of adverse events as indicators.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Overall survival OS:
It is defined as the period from the treatment start date to the death date due to any cause. In surviving cases, we will terminate halfway with the date of final survival confirmation. In the case of non-follow-up cases, we aborted by the last day that survival was confirmed before becoming impossible to pursue.
Key secondary outcomes PFS by RANO standard:
It is defined as the period from the treatment start date to the day when the progression of disease (PD) based on the RANO standard, or until the death date due to any cause. In cases that did not deteriorate, we abort halfway with the final progression-free evacuation date (the date of making a decision other than deterioration). In the case of non-follow-up cases, we abort halfway with the final progression-free confirmation date before becoming impossible to pursue.

Expression of adverse events:
Evaluate adverse events and serious adverse events that occurred during treatment or within 30 days after the end of treatment. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0).

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
Maneuver
Interventions/Control_1 Protocol treatments consist of BNCT, additional and chemotherapy with bevacizumab. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional bevacizumab is given biweekly with 10 mg/kg as long as progressive disease judged by RANO criteria.
Here: RPA class 3 is non-GBM as initial histology and poor KPS less than 70%. RPA class 7 is GBM as initial histology, age more than 50 and steroids required to maintain ADL. Subgroup of RPA class 7 is GBM as initial histology, age more than 50 and the effect was not seen using BV as an antitumor agent.
The MST of these classes is reported as 4.4 months after the recurrence.
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
15 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who are histopathologically diagnosed with glioma
2. Patients who have relapsed after standard treatment (including BV)
3. Patients with recurrent gliomas that have a poor prognosis that falls under any of the following
- It is not GBM in the initial histopathological examination, KPS at recurrence is 60% to 70% (RPA class 3)]
- It is GBM in the initial histopathological examination, the age at recurrence was over 50 years old and used steroid (RPA class 7)
- It is GBM in the initial histopathological examination, the age at recurrence was over 50 years old, and the effect was not seen using BV as an antitumor agent (subgroup of RPA class 7)
4. Patients who have confirmed the following in MRI images taken within 28 days prior to BNCT therapy
- Case where the tumor is confined to the one side hemisphere on the supratentorial area, the deepest part is within 60 mm from the scalp (Even if the deepest part is 60 mm or more, cases that are judged to be irradiable by air substitution to the tumor excision cavity are indicated as adaptation).
- It is single-shot and does not allow seeding.
5. Patients who aged 15 years or older and under 85 years of age at the time of acquiring consent.
6. Patients with KPS of 60% or more
7. Patients who are expected to survive more than 3 months at the time of acquiring consent
8. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment
- Leukocyte count 3,000 /microlitter or more, Neutrophil count 1,500 /microlitter or more, Hemoglobin 8.0 g/dL or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less, Total bilirubin 1.5 mg/dL or less, Serum creatinine 1.2 mg/dL or less, Urine protein 1+ or less, PT-INR 1.6 or less
9. Patient's consent to participate in this study was obtained in writing from the patient himself
Key exclusion criteria 1. Patients suspected of cerebral radiation necrosis at enrollment
2. Patients with infections requiring intravenous administration such as antibiotics, antivirals, antifungal drugs
3. Patients with fever (over 38C)
4. Patients with serious complications / previous medical history
- Unstable angina pectoris, myocardial infarction complications, past within 6 months
- Digestive ulcer with poor control
- Poor control hypertension, diabetes
- Advanced wounds that are not approved for healing, traumatic fractures
- Digestive tract perforation, fistula, abdominal abscess complications, past within 6 months
- Complication of CTCAE Grade 2 or higher pulmonary hemorrhage (hemoptysis [excretion of occult blood over 2.5 ml]), past history
- Complication of vascular disorders (venous / arterial thrombus, embolism, aortic aneurysm) requiring treatment, past within 6 months
- Complication of congestive heart failure of II degree or more in NYHA
- Pulmonary fibrosis / interstitial pneumonia requiring treatment (CTCAE Grade 2 or higher)
- Patients scheduled for surgery during the study or patients under 4 weeks from surgical therapy
5. Patients with phenylketonuria
6. Current bleeding (intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage, retroperitoneal hemorrhage, hemoptysis, etc.)
7. Under anticoagulant medication, control is unstable or PT-INR is more than 2.5
8. Severe hypersensitivity to components of BPA and BV
9. Pregnant woman or lactating woman
10. Patients who do not agree to contraception participating in this study
11. Patients who participated in other clinical trials within one month prior to acquiring consent
12. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Department of Neurosurgery
Zip code
Address Daigakumachi, 2-7, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email neu070@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 Department of Neurosurgery
Zip code
Address Daigakumachi, 2-7, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email neu070@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Translational Research Informatics Center, Foundation for Biomedical Research and Innovation

Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 TRIBRAIN1705
Org. issuing International ID_1 Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 10 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
2017 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 10 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
2017 Year 09 Month 14 Day
Last modified on
2017 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033313

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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