To hear about similar clinical trials, please enter your email below
Trial Title:
Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence
NCT ID:
NCT05611645
Condition:
Glioma
Recurrent Glioma
Conditions: Official terms:
Glioma
Recurrence
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated Stereotactic Radiotherapy
Description:
Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on
consecutive treatment days.
Arm group label:
HSRT+Low-dose Bevacizumab
Other name:
Hypofractionated Stereotactic Radiosurgery
Other name:
Image-Guided Radiation Treatment (IGRT)
Other name:
Stereotactic Radiosurgery (SRS)
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Staring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg
(comparison group) every two weeks until disease progression.
Arm group label:
Bevacizumab
Arm group label:
HSRT+Low-dose Bevacizumab
Other name:
anti-VEGF monoclonal antibody
Other name:
rhuMAb VEGF
Other name:
Avastin
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.
Detailed description:
To establish an improvement in 6-month pfs in recurrent glioblastoma patients receiving
low-dose bevacizumab and re-irradiation compared with patients receiving bevacizumab
alone.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-70 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CyberKnife Center, Department of Neurosurgery, Huashan Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Start date:
October 1, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05611645
