Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence

Fudan University

Status and phase: Active, not recruiting; Phase 2

Conditions: Glioma; Recurrent Glioma

Treatments: Radiation: Hypofractionated Stereotactic Radiotherapy; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05611645

KY2022-798

Details and patient eligibility

About

This randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.

Full description

To establish an improvement in 6-month pfs in recurrent glioblastoma patients receiving low-dose bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 years of age;
• Karnofsky performance status (KPS) ≥ 60;
• Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma;
• Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven;
• Measurable disease;
• Estimated survival of at least 3 months, maximal diameter on T1+C MRI ≤ 3.5 cm;
• Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;
• Signed informed consent form;
• Agreed to participate the follow-up.

Exclusion criteria

• Prior invasive malignancy unless disease free;
• Received re-irradiation;
• More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter;
• Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
• Pregnancy or or nursing mothers;
• Participated in other trials after diagnosis of recurrent;
• Influence factors toward oral medications;
• Patients with CTCAE5.0 grade 3+ bleeding;
• Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
• Long-term unhealed wounds or fractures;
• History of organ transplantation;
• Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

HSRT+Low-dose Bevacizumab

Experimental group

Description:

HSRT with low-dose bevacizumab every 2 weeks

Treatment:

Drug: Bevacizumab

Radiation: Hypofractionated Stereotactic Radiotherapy

Bevacizumab

Active Comparator group

Description:

Bevacizumab every 2 weeks

Treatment:

Drug: Bevacizumab