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

NCT05611645 | Unknown Phase 2 FDA Drug FDA Device

• 1 other identifier: KY2022-798
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma; Recurrent Glioma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival rate at 6 Months

  Prgression was defined using Response Assessment in Neuro-Oncology (RANO) Criteria. Progression-free at 6 months means patient alive without progression at 6 months. Survival rates are estimated by the Kaplan-Meier method.

  From randomization to six months

Secondary Outcomes (6)

• Overall Survival

  From randomization to last follow-up, up to approximately 24 months

• Progression-free Survival

  From randomization to last follow-up, up to approximately 24 months

• Objective response rate

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

• Number of Participants With Grade 3+ Toxicity rate

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

• Quality of Life score (QoL)

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

Study Arms (2)

HSRT+Low-dose Bevacizumab

EXPERIMENTAL

HSRT with low-dose bevacizumab every 2 weeks

Radiation: Hypofractionated Stereotactic Radiotherapy; Drug: Bevacizumab

Bevacizumab

ACTIVE COMPARATOR

Bevacizumab every 2 weeks

Drug: Bevacizumab

Interventions

Hypofractionated Stereotactic Radiotherapy RADIATION

Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on consecutive treatment days.

Also known as: Hypofractionated Stereotactic Radiosurgery, Image-Guided Radiation Treatment (IGRT), Stereotactic Radiosurgery (SRS)

HSRT+Low-dose Bevacizumab

Bevacizumab DRUG

Staring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg (comparison group) every two weeks until disease progression.

Also known as: anti-VEGF monoclonal antibody, rhuMAb VEGF, Avastin

Bevacizumab; HSRT+Low-dose Bevacizumab

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 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.

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 (2)

• 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 BACKGROUND

• Guan Y, Xiong J, Pan M, Shi W, Li J, Zhu H, Gong X, Li C, Mei G, Liu X, Pan L, Dai J, Wang Y, Wang E, Wang X. Safety and efficacy of Hypofractionated stereotactic radiosurgery for high-grade Gliomas at first recurrence: a single-center experience. BMC Cancer. 2021 Feb 5;21(1):123. doi: 10.1186/s12885-021-07856-y.

  PMID: 33546642 BACKGROUND

MeSH Terms

Conditions

Glioma

Interventions

Radiosurgery; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, CyberKnife Center

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)