GliomaPhase 2NCT05611645
Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence
A Phase 2 study testing Hypofractionated Stereotactic Radiotherapy and Bevacizumab in people with Glioma and Recurrent Glioma, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Recurrent Glioma
- What is being tested?
- Hypofractionated Stereotactic Radiotherapy and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
CyberKnife Center, Department of Neurosurgery, Huashan Hospital
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Randomized Phase II Trial of Concurrent Low-dose Bevacizumab and HSRT Versus Bevacizumab Alone for Glioblastoma at First Recurrence: HSCK-005
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.
Read the 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.
- Conditions
- Glioma, Recurrent Glioma
- Being tested
- Hypofractionated Stereotactic Radiotherapy, Bevacizumab
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Stereotactic RadiotherapyRadiation
Also called Hypofractionated Stereotactic Radiosurgery, Image-Guided Radiation Treatment (IGRT), Stereotactic Radiosurgery (SRS)
Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on consecutive treatment days.
BevacizumabDrug
Also called anti-VEGF monoclonal antibody, rhuMAb VEGF, Avastin
Staring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg (comparison group) every two weeks until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| HSRT+Low-dose Bevacizumab | Experimental | HSRT with low-dose bevacizumab every 2 weeks Receives: Radiation: Hypofractionated Stereotactic Radiotherapy; Drug: Bevacizumab |
| Bevacizumab | Active comparator | Bevacizumab every 2 weeks Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to six months
Secondary outcomes (6)
Overall Survival
Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method.
Measured: From randomization to last follow-up, up to approximately 24 months
Progression-free Survival
Prgression was defined using Response Assessment in Neuro-Oncology (RANO) Criteria. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.
Measured: From randomization to last follow-up, up to approximately 24 months
Objective response rate
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Assessment in Neuro-Oncology (RANO) prior to progression or any further therapy.
Measured: Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months
Number of Participants With Grade 3+ Toxicity rate
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade refers to the severity of the AE. Estimated using an exact binomial distribution together with 95% confidence interval. The difference between the two groups will be tested using a chi square test.
Measured: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Quality of Life score (QoL)
EORTC QLQ-C30 (version 3.0) questionnaire to evaluate the quality of life. All scales range in score from 0 to 100. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Cognitive function
Mini-Mental State Exam (MMSE, score range 0 to 30) to evaluate the cognitive function. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Measured: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Guan, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611645
- Sponsor's protocol ID
- KY2022-798
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35448002Guan 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.
PubMed 33546642
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Concurrent Low-dose Bevacizumab and HSRT Versus Bevacizumab Alone for Glioblastoma at First Recurrence: HSCK-005
- ClinicalTrials.gov ID
- NCT05611645
- Acronym / sponsor ID
- KY2022-798
- Conditions
- Glioma, Recurrent Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSRT+Low-dose Bevacizumab | Experimental | Radiation: Hypofractionated Stereotactic Radiotherapy, Drug: BevacizumabHSRT with low-dose bevacizumab every 2 weeks |
| Bevacizumab | Active comparator | Drug: BevacizumabBevacizumab every 2 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Stereotactic RadiotherapyAlso: Hypofractionated Stereotactic Radiosurgery, Image-Guided Radiation Treatment (IGRT), Stereotactic Radiosurgery (SRS)Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on consecutive treatment days. | Radiation | HSRT+Low-dose Bevacizumab |
| BevacizumabAlso: anti-VEGF monoclonal antibody, rhuMAb VEGF, AvastinStaring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg (comparison group) every two weeks until disease progression. | Drug | Bevacizumab, HSRT+Low-dose Bevacizumab |
Primary outcome
Progression-free Survival rate at 6 Months
Time frame: From randomization to six 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.
6 secondary outcomes
Overall Survival
Time frame: From randomization to last follow-up, up to approximately 24 months
Progression-free Survival
Time frame: From randomization to last follow-up, up to approximately 24 months
Objective response rate
Time frame: Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months
Number of Participants With Grade 3+ Toxicity rate
Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Quality of Life score (QoL)
Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Cognitive function
Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 35448002Guan 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.
- Background: PubMed 33546642Guan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated Stereotactic Radiotherapy and Bevacizumab in people with Glioma and Recurrent Glioma, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival rate at 6 Months (time frame: From randomization to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611645, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.