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

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital

Criteria

Inclusion Criteria:

1. 18-70 years of age;

2. Karnofsky performance status (KPS) ≥ 60;

3. Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma;

4. 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;

5. Measurable disease;

6. Estimated survival of at least 3 months;

7. 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;

8. Signed informed consent form;

9. Agreed to participate the follow-up.

Exclusion Criteria:

1. Prior invasive malignancy unless disease free;

2. Received re-irradiation;

3. More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter;

4. Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;

5. Pregnancy or or nursing mothers;

6. Participated in other trials after diagnosis of recurrent;

7. Influence factors toward oral medications;

8. Patients with CTCAE5.0 grade 3+ bleeding;

9. 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%;

10. Long-term unhealed wounds or fractures;

11. History of organ transplantation;

12. Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.