UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory phase II study of neoadjuvant bevacizumab and temozolomide chemotherapy for patients with newly diagnosed malignant glioma
Title of the study (Brief title)	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	Hikaru Sasaki
Organization	Keio university school of medicine
Division name	Department of Neurosurgery
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	Hikaru Sasaki
Organization	Keio university school of medicine
Division name	Department of Neurosurgery
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)

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

Progress
Recruitment status
Date of protocol fixation	2017 Year 01 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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