Glioma PatientsNCT07847476
Flubendazole Added to Standard Concurrent Chemoradiotherapy With Temozolomide in Patients With High-Grade Glioma
A study testing Flubendazole in people with Glioma Patients, run by Assiut University.
Trial summary
This study To evalute the efficacy and safety of adding flubendazole to standard concurrent chemoradiotherapy with temozolomide in patients with high grade glioma and also to evaluate DFS,OS for those patients in clinical oncology department , Assiut university Hospital . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma Patients
- What is being tested?
- Flubendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥18 years.
- Male or female
- Histologically confirmed high grade glioma (WHO grade 3(III) and grade 4 IV) after surgery.
- ECOG PS 0-2
- Fit patient for concurrent chemoradiotherapy.
Who cannot join
- Age ≥80 years.
- presence of another active malignancy .
- known hypersensitivity to flubendazole.
- pregnant or breastfeeding women.
- inability to comply with study requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study of Adding Flubendazole to Standard Concurrent Chemoradiotherapy With Temozolomide in Patients With High-Grade Glioma
This study To evalute the efficacy and safety of adding flubendazole to standard concurrent chemoradiotherapy with temozolomide in patients with high grade glioma and also to evaluate DFS,OS for those patients in clinical oncology department , Assiut university Hospital .
Read the detailed description
High grade glioma is the most common and lethal primary brain cancer, arising from glial stem cells . It is characterized by rapid growth, and a poor prognosis .Despite an intensive standard-of-care therapeutic approach combining surgical resection, radiotherapy, and chemotherapy with Temozolomide (TMZ) , survival rates remain low, with an almost inevitable recurrence . The median overall survival is only 12 to 15 months after diagnosis .Despite this scenario, no significant therapeutic advances have been recorded in the past 20 years. Innovative approaches such as tumor-treating fields, immunotherapies, and stem cell-based therapies have reached clinical trials, but clinical benefits remain limited . Therefore, there is an urgent need to identify new strategies to overcome the resistance of this type of cancer. A key contributor to treatment failure is the pronounced cellular heterogeneity of glioma, which resembles the complexity of a developing organ and contains cells with stem-like properties.There are a therapeutic agents that inhibit mitochondrial biogenesis also include antibiotics, anthelmintics, and antimycobacterial drugs. Flubendazole (FLU) is a member of the benzimidazole group, a drug commonly used in veterinary and human medicine for its anthelmintic properties. This anthelmintic effect is based on its ability to bind to β-tubulin, which causes inhibition of tubulin polymerization leading to microtubule disruption and loss of function . These effects are thought to be mediated not only via microtubule disruption but also via interference with several signaling pathways, including IL/JAK/STAT3, AKT, NF-κB and others, ultimately to cell cycle arrest, autophagy, apoptosis and/or other types of cell death .
- Conditions
- Glioma Patients
- Being tested
- Flubendazole
- Keywords
- Flubendazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlubendazoleDrug
Flubendazole 100 mg twice daily for 3 day in the week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Flu | Active comparator | Flubendazole 100 mg twice daily for 3 day in the week for 6 weeks Receives: Drug: Flubendazole |
| Pt will receive concurrent chemo radiotherapy with TMZ with placebo | No intervention | Pt will receive CCRth with TMZ with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
Treatment-related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The number and severity of treatment-related adverse events occurring during concurrent chemoradiotherapy will be recorded
Measured: From baseline until 30 days after completion of concurrent chemoradiotherapy
Change in complete blood count (CBC)
Complete blood count parameters, including hemoglobin, white blood cell count, absolute neutrophil count, and platelet count, will be assessed weekly during concurrent chemoradiotherapy to evaluate hematologic toxicity.
Measured: Baseline and weekly during concurrent chemoradiotherapy ,up to 6 weeks
"Mean change in liver function test levels from baseline to end of treatment"
Liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase, will be assessed weekly during concurrent chemoradiotherapy to evaluate hepatic toxicity.
Measured: Baseline and weekly during concurrent chemoradiotherapy ,up to 6 weeks
Secondary outcomes (1)
* Disease free survival (DFS)
is calculated from the date of randomization until the date of the first cancer-related event ,second cancer ,or death from. any cause
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Saber Khalifa Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847476
- Sponsor's protocol ID
- ASSIUT-FLUBE-001
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adding Flubendazole to Standard Concurrent Chemoradiotherapy With Temozolomide in Patients With High-Grade Glioma
- ClinicalTrials.gov ID
- NCT07847476
- Acronym / sponsor ID
- ASSIUT-FLUBE-001
- Conditions
- Glioma Patients
- Keywords
- Flubendazole
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 Sep 2026 (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 study To evalute the efficacy and safety of adding flubendazole to standard concurrent chemoradiotherapy with temozolomide in patients with high grade glioma and also to evaluate DFS,OS for those patients in clinical oncology department , Assiut university Hospital .
Detailed description
High grade glioma is the most common and lethal primary brain cancer, arising from glial stem cells . It is characterized by rapid growth, and a poor prognosis .Despite an intensive standard-of-care therapeutic approach combining surgical resection, radiotherapy, and chemotherapy with Temozolomide (TMZ) , survival rates remain low, with an almost inevitable recurrence . The median overall survival is only 12 to 15 months after diagnosis .Despite this scenario, no significant therapeutic advances have been recorded in the past 20 years. Innovative approaches such as tumor-treating fields, immunotherapies, and stem cell-based therapies have reached clinical trials, but clinical benefits remain limited . Therefore, there is an urgent need to identify new strategies to overcome the resistance of this type of cancer. A key contributor to treatment failure is the pronounced cellular heterogeneity of glioma, which resembles the complexity of a developing organ and contains cells with stem-like properties.There are a therapeutic agents that inhibit mitochondrial biogenesis also include antibiotics, anthelmintics, and antimycobacterial drugs. Flubendazole (FLU) is a member of the benzimidazole group, a drug commonly used in veterinary and human medicine for its anthelmintic properties. This anthelmintic effect is based on its ability to bind to β-tubulin, which causes inhibition of tubulin polymerization leading to microtubule disruption and loss of function . These effects are thought to be mediated not only via microtubule disruption but also via interference with several signaling pathways, including IL/JAK/STAT3, AKT, NF-κB and others, ultimately to cell cycle arrest, autophagy, apoptosis and/or other types of cell death .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flu | Active comparator | Drug: FlubendazoleFlubendazole 100 mg twice daily for 3 day in the week for 6 weeks |
| Pt will receive concurrent chemo radiotherapy with TMZ with placebo | No intervention | –Pt will receive CCRth with TMZ with placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Age ≥18 years.
- Male or female
- Histologically confirmed high grade glioma (WHO grade 3(III) and grade 4 IV) after surgery.
- ECOG PS 0-2
- Fit patient for concurrent chemoradiotherapy.
Key exclusion criteria (5 listed)
- Age ≥80 years.
- presence of another active malignancy .
- known hypersensitivity to flubendazole.
- pregnant or breastfeeding women.
- inability to comply with study requirements.
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 |
|---|---|---|
| FlubendazoleFlubendazole 100 mg twice daily for 3 day in the week for 6 weeks | Drug | Flu |
Primary outcome
Incidence of treatment-related adverse events
Time frame: From baseline until 30 days after completion of concurrent chemoradiotherapy
Treatment-related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The number and severity of treatment-related adverse events occurring during concurrent chemoradiotherapy will be recorded
Change in complete blood count (CBC)
Time frame: Baseline and weekly during concurrent chemoradiotherapy ,up to 6 weeks
Complete blood count parameters, including hemoglobin, white blood cell count, absolute neutrophil count, and platelet count, will be assessed weekly during concurrent chemoradiotherapy to evaluate hematologic toxicity.
"Mean change in liver function test levels from baseline to end of treatment"
Time frame: Baseline and weekly during concurrent chemoradiotherapy ,up to 6 weeks
Liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase, will be assessed weekly during concurrent chemoradiotherapy to evaluate hepatic toxicity.
1 secondary outcome
* Disease free survival (DFS)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Flubendazole in people with Glioma Patients, run by Assiut University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Saber Khalifa, MD (+201143980715, ayasaber66778899@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (time frame: From baseline until 30 days after completion of concurrent chemoradiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.