NCT04197492

Hypofractionated Stereotactic Radiotherapy With Anlotinib in Patients With Recurrent High-Grade Gliomas

A Phase II Study of Hypofractionated Stereotactic Radiotherapy Combined With Anlotinib in Patients With Recurrent High-Grade Glioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Study of Hypofractionated Stereotactic Radiotherapy (HSRT) With Anlotinib in Patients With Recurrent High-Grade Glioma. The primary endpoint is overall survival after radiotherapy. Secondary endpoints included progress-free survival, objective response rate, cognitive function, quality of life, toxicity.

Detailed description

Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma patients who underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol). Recurrence based on Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathology. Intervention included CyberKnife hypofractionated stereotactic radiotherapy (25Gy/5fx) with Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
RADIATION	Hypofractionated Stereotactic Radiotherapy	Hypofractionated stereotactic radiotherapy (CyberKnife, 25Gy/5fx)
DRUG	Anlotinib	Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.

Timeline

• Start date: 2019-12-16
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2019-12-13
• Last updated: 2024-01-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study