Recurrent or Progressive GlioblastomaPhase 3NCT05718466
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
A Phase 3 study testing Bevacizumab, Chemotherapy and Fractionated radiosurgery in people with Recurrent or Progressive Glioblastoma, run by Henry Ford Health System at 1 site in United States.
Trial summary
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Recurrent or Progressive Glioblastoma
- What is being tested?
- Bevacizumab, Chemotherapy and Fractionated radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
- Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
- History and physical exam, including neurologic examination, within 4 weeks prior to registration
Who cannot join
- Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.
- Conditions
- Recurrent or Progressive Glioblastoma
- Being tested
- Bevacizumab, Chemotherapy, Fractionated radiosurgery
- Keywords
- glioblastoma
- Medical subject headings
- Recurrence, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
ChemotherapyDrug
Also called Either irinotecan or temozolomide or carboplatin or etoposide
Fractionated radiosurgeryRadiation
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Radiosurgery and Bevacizumab | Experimental | FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression Receives: Drug: Bevacizumab; Drug: Chemotherapy; Radiation: Fractionated radiosurgery |
| Bev with Chemo | Active comparator | Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression Receives: Drug: Bevacizumab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control
Measured: 2 months
Overall Survival
Measured: 12 months
Progression Free Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startNov 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent or Progressive GlioblastomaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salim Siddiqui, MD, PhD, Henry Ford Health System
- Investigators
- Farzan Siddiqui, MD, Study director, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718466
- Sponsor's protocol ID
- HFHS-C 11-01
- Status last verified
- Jun 2023
- First submitted
- 26 Feb 2014
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy
- ClinicalTrials.gov ID
- NCT05718466
- Acronym / sponsor ID
- HFHS-C 11-01
- Conditions
- Recurrent or Progressive Glioblastoma
- Keywords
- glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractionated Radiosurgery and Bevacizumab | Experimental | Drug: Bevacizumab, Drug: Chemotherapy, Radiation: Fractionated radiosurgeryFRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression |
| Bev with Chemo | Active comparator | Drug: Bevacizumab, Drug: ChemotherapyBev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
- Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
- History and physical exam, including neurologic examination, within 4 weeks prior to registration
Key exclusion criteria (1 listed)
- Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
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 |
|---|---|---|
| Bevacizumab | Drug | Bev with Chemo, Fractionated Radiosurgery and Bevacizumab |
| ChemotherapyAlso: Either irinotecan or temozolomide or carboplatin or etoposide | Drug | Bev with Chemo, Fractionated Radiosurgery and Bevacizumab |
| Fractionated radiosurgery | Radiation | Fractionated Radiosurgery and Bevacizumab |
Primary outcome
Local Tumor Control
Time frame: 2 months
Overall Survival
Time frame: 12 months
Progression Free Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Farzan Siddiqui, MD study director
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab, Chemotherapy and Fractionated radiosurgery in people with Recurrent or Progressive Glioblastoma, run by Henry Ford Health System at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2023. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Local Tumor Control (time frame: 2 months). 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 17 Jul 2023.