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

NCT ID: NCT04197492

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HSRT With Anlotinib

• Hypofractionated stereotactic radiotherapy using CyberKnife 25Gy/5fx, 5 days a week for 1 week.
• Anlotinib once daily (12mg/d) orally administered on days 1-14 of a 21-day cycle until disease progression or treatment intolerance.

Group Type: EXPERIMENTAL

Hypofractionated Stereotactic Radiotherapy

Intervention Type: RADIATION

Hypofractionated stereotactic radiotherapy (CyberKnife, 25Gy/5fx)

Anlotinib

Intervention Type: DRUG

Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.

Interventions

Hypofractionated Stereotactic Radiotherapy

Hypofractionated stereotactic radiotherapy (CyberKnife, 25Gy/5fx)

Intervention Type: RADIATION

Anlotinib

Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.

Intervention Type: DRUG

Other Intervention Names

Hypofractionated Stereotactic Radiosurgery; AL3818

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chongbo Zhao

Head of CyberKnife Center, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enmin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Wuthrick EJ, Curran WJ Jr, Camphausen K, Lin A, Glass J, Evans J, Andrews DW, Axelrod R, Shi W, Werner-Wasik M, Haacke EM, Hillman GG, Dicker AP. A pilot study of hypofractionated stereotactic radiation therapy and sunitinib in previously irradiated patients with recurrent high-grade glioma. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):369-75. doi: 10.1016/j.ijrobp.2014.05.034. Epub 2014 Aug 4.

Reference Type: BACKGROUND

PMID: 25104067 (View on PubMed)

Clarke J, Neil E, Terziev R, Gutin P, Barani I, Kaley T, Lassman AB, Chan TA, Yamada J, DeAngelis L, Ballangrud A, Young R, Panageas KS, Beal K, Omuro A. Multicenter, Phase 1, Dose Escalation Study of Hypofractionated Stereotactic Radiation Therapy With Bevacizumab for Recurrent Glioblastoma and Anaplastic Astrocytoma. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):797-804. doi: 10.1016/j.ijrobp.2017.06.2466. Epub 2017 Jun 30.

Reference Type: BACKGROUND

PMID: 28870792 (View on PubMed)

Minniti G, Scaringi C, De Sanctis V, Lanzetta G, Falco T, Di Stefano D, Esposito V, Enrici RM. Hypofractionated stereotactic radiotherapy and continuous low-dose temozolomide in patients with recurrent or progressive malignant gliomas. J Neurooncol. 2013 Jan;111(2):187-94. doi: 10.1007/s11060-012-0999-9. Epub 2012 Nov 6.

Reference Type: BACKGROUND

PMID: 23129347 (View on PubMed)

Guan Y, Li J, Gong X, Zhu H, Li C, Mei G, Liu X, Pan L, Dai J, Wang Y, Wang E, Liu Y, Wang X. Safety and Efficacy of Hypofractionated Stereotactic Radiotherapy with Anlotinib Targeted Therapy for Glioblastoma at the First Recurrence: A Preliminary Report. Brain Sci. 2022 Apr 2;12(4):471. doi: 10.3390/brainsci12040471.

Reference Type: DERIVED

PMID: 35448002 (View on PubMed)

Other Identifiers

HSCK-002

Identifier Type: OTHER

Identifier Source: secondary_id

KY2019-525

Identifier Type: -

Identifier Source: org_study_id