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

NCT04197492 | Unknown Phase 2 FDA Device

• 2 other identifiers: KY2019-525HSCK-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma

Keywords

Hypofractionated Stereotactic Radiotherapy; Recurrent High-grade Glioma; Anlotinib

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Estimated using the Kaplan-Meier method

  From the start of treatment to the date of death or the last follow-up, up to approximately 24 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  From the start of treatment to the date of disease progression or death, up to approximately 24 months

• Objective response rate (ORR)

  Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months

• Quality of Life score (QoL): European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0

  Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months

• Cognitive function

  Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months

• Toxicity rate

  Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months

Study Arms (1)

HSRT With Anlotinib

EXPERIMENTAL

* 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.

Radiation: Hypofractionated Stereotactic Radiotherapy; Drug: Anlotinib

Interventions

Hypofractionated Stereotactic Radiotherapy RADIATION

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

Also known as: Hypofractionated Stereotactic Radiosurgery

HSRT With Anlotinib

Anlotinib DRUG

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

Also known as: AL3818

HSRT With Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• Karnofsky performance status (KPS) ≥ 60;
• Original histopathologically proven diagnosis World Health Organization (WHO) Grade 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (4)

• 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.

  PMID: 25104067 BACKGROUND

• 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.

  PMID: 28870792 BACKGROUND

• 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.

  PMID: 23129347 BACKGROUND

• 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.

  PMID: 35448002 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Enmin Wang, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of CyberKnife Center, Principal Investigator

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: December 16, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)