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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025579
Receipt No. R000029437
Scientific Title An exploratory phase II study of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with newly diagnosed malignant glioma
Date of disclosure of the study information 2017/01/16
Last modified on 2018/01/09

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Basic information
Public title An exploratory phase II study of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with newly diagnosed malignant glioma
Acronym Neoadjuvant bevacizumab and temozolomide for malignant glioma
Scientific Title An exploratory phase II study of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with newly diagnosed malignant glioma
Scientific Title:Acronym Neoadjuvant bevacizumab and temozolomide for malignant glioma
Region
Japan

Condition
Condition malignant glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 An exploratory phase II study to evaluate the safety and efficacy of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with primary malignant glioma suspected by imaging findings, clinical course, and laboratory data.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes safety (adverse event related to neoadjuvant chemotherapy, the rate of accomplishment of the planned operation following neoadjuvant chemotherapy)
response rate for neoadjuvant bevacizumab and temozolomide chemotherapy
(Response assessment in neuro-oncology (RANO) and tumor volume decrease according to sum of products of diameters (SPD))
two year survival rate
overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Tumor is removed 21~30 days after one course of neoadjuvant bevacizumab and temozolomide chemotherapy. Radiation and temozolomide combination therapy is initiated more than 10 days after the operation. Maintenance phase of temozolomide monotherapy (5/28 schedule, at least 6 courses) is initiated 28 days after the completion of radiochemotherapy.
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
18 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Newly diagnosed supratentorial malignant glioma primarily by imaging findings (ring enhancement and marked peritumoral edema on MRI) that is expected to gain a benefit from the neoadjuvant strategy (ex.hypervascular tumor, tumors with invasion into eloquent area).
2) Age between 18 to 75
3) Performance status (ECOG) of 0-2
4) Sufficient function of important organs.
Neu>1,500/mm3, Hb>8.0 g/dL, Plt>100,000/mm3, AST and ALT<3 times normal value, Bil<2.0 mg/dL, Cr<1.5 mg/dL, ECG: normal, lung function:SpO2>92%
5) Written informed consents are obtained.
Key exclusion criteria 1) Uncontrollable severe infectious diseases.
2) Presence of active other cancers.
3) History of radiotherapy for head
4) Uncontrollable hypertention: SAP>150mmHg, DBP>100mmHg
5) Clinically significant cardiac disease (ex. congestive heart failure:NYHA gradeII)
6) Symptomatic myocardial infarction, cerebral infarction, deep vein thrombosis and pulmonary embolism within 6 months
7) Symptomatic intracerebral hemorrhage within 6 months
8) Hemoptysis within 28 days (CTCAE v4.0: grade2)
9) Bleeding diathesis and blood coagulation disorder
10) Unhealed scar and untreated bone fracture
11) Severe gastric ulcer
12) Pulmonary fibrosis and interstitial pneumonia
13) Pregnancy or lactation. Patients hope pregnancy
14) Allergy for temozolomide or bevacizumab
15) Allergy for gadolinium
16) Judged as inappropriate for this study by doctors.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hikaru Sasaki
Organization Keio university school of medicine
Division name Department of Neurosurgery
Zip code
Address Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Email hsasaki@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hikaru Sasaki
Organization Keio university school of medicine
Division name Department of Neurosurgery
Zip code
Address Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Homepage URL http://www.neurosurgery.med.keio.ac.jp/medic/clinical_research.html
Email hsasaki@keio.jp

Sponsor
Institute Keio university school of medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Jikei University Kashiwa Hospital
Kagawa University Hospital
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
2017 Year 01 Month 16 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
Date of protocol fixation
2017 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 16 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 01 Month 09 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029437

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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