UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025579 |
|---|---|
| Receipt number | 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 20:39:20 |
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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
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
hsasaki@keio.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029437
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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