eoadjuvant bevacizumab and temozolomide chemotherapy for malignant glioma

Phase 2

• Conditions: D005910; malignant glioma

• Registration Number: JPRN-jRCT1031180233
• Lead Sponsor: Tamura Ryota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
safety (adverse event related to neoadjuvant chemotherapy, the rate of accomplishment of the planned operation following neoadjuvant chemotherapy) <br>response rate for neoadjuvant bevacizumab and temozolomide chemotherapy <br>(Response assessment in neuro-oncology (RANO) and tumor volume decrease according to sum of products of diameters (SPD)) <br>two year survival rate <br>overall survival