Recurrent GlioblastomaNCT04838782
Role of Repeat Resection in Recurrent Glioblastoma
A study testing Repeat Surgical Management of Recurrent GBM in people with Recurrent Glioblastoma and Glioblastoma - Category, run by University of Alberta at 1 site in Canada.
Trial summary
Patients with recurrent Glioblastoma (GBM) are commonly presented to surgeons, along with the question of whether or not to re-resect the recurrence. There is no Level 1 evidence to support a role for repeat surgery in this context, but a multitude of observational research suggests that repeat surgery may improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma, Glioblastoma - Category
- What is being tested?
- Repeat Surgical Management of Recurrent GBM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2021to 24 Mar 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Previously histologically confirmed and surgically resected Glioblastoma
- Previous craniotomy for open tumor resection (needle biopsies alone do not count as resection)
- The attending surgeon considers re-operation may improve quality survival
Who cannot join
- Informed consent not possible
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta Division of Neurosurgery
Edmonton, Alberta, T6G 2B7
About this study
Official title: Role of Repeat Resection in Recurrent Glioblastoma (4rGBM) Trial: a Randomized Care Trial for Patients With Recurrent GBM
Patients with recurrent Glioblastoma (GBM) are commonly presented to surgeons, along with the question of whether or not to re-resect the recurrence. There is no Level 1 evidence to support a role for repeat surgery in this context, but a multitude of observational research suggests that repeat surgery may improve quality survival. Unfortunately, these studies all suffer from selection bias.
The goal of this study is to provide a care trial context to help neurosurgeons manage patients presenting with recurrent GBM, with no additional risks, tests, or interventions than what they would normally encounter in routine care. Secondary goals include a test of the hypothesis that repeat resection can improve median overall survival, and that it can increase the number of days of survival outside of a hospital/nursing/palliative care facility.
Read the detailed description
Glioblastoma (GBM) is the most common malignant brain tumor (48.3% of malignant tumors).1 It has a predilection for Caucasian men with a mean age of 65.1, 2 There are approximately 13,000 new diagnoses of GBM made every year in the United States.1 Patients have an average survival of 12-15 months, with a 5-year survival rate of 6.8% despite various treatments.1 If the prognosis at the time of initial diagnosis is grim, it is even worse at the time of recurrence. Recurrence after the initial resection, which can be symptomatic or discovered on surveillance MRI imaging, occurs in nearly all patients, usually within the first year, even when the initial management is aggressive.3-6 There is no standard way to care for recurrent GBM patients and treatment may include one or more of the following: repeat surgery, radiation therapy, or second-line chemotherapy.7
Repeat surgical management carries a greater risk of wound infection and cerebrospinal fluid leak than the initial surgery, especially in patients who received radiation.8 When maximal resection was attempted at the time of the initial procedure, the second surgery is more at risk of neurological injury. Repeat surgical management often also entails a delay in the initiation of further chemotherapy, as these agents are not administered peri-operatively because of potentially deleterious effects on wound healing. Nonetheless, despite, or because of the desperate setting, patients and surgeons are often pressed to consider repeat surgery, which is performed in at least 10-30% of patients.9 Repeat surgical treatment may be more favorable with younger age (<60 years), and preoperative Karnofsky performance status (KPS) of at least 70.9 Median survival following repeat resection varies between 13-54 weeks,10, 11 but all reports suffer from the limitations of retrospective studies, the most obvious being selection bias in terms of patient age, functional status, tumor location and size.11, 12 Yet, despite favorable biases some studies report no improvement in terms of survival or quality of life.13, 14 Two recent systematic meta-analyses of case series offer conflicting conclusions about the merit of re-operation.15, 16
If the intent of repeat surgery is to improve quality and quantity of life, there is no level 1 evidence it is effective.3, 16, 17 Thus repeat surgery should be considered the experimental arm of a randomized trial designed in the best interest of the patient, being only offered as a 50% chance, always balanced by a 50% chance of being allocated non-surgical care, or a chance to escape what could turn out to be unnecessary or harmful surgery.18 For patients may be better served by being free to pursue other life priorities in the company of loved ones rather than being scheduled to endure repeat craniotomy and multiple clinical or research follow-up visits. There is sufficient community equipoise to support the conduct of such a randomized trial.19
Tria Design:
The trial is a simple, all-inclusive, prospective, multicenter, randomized care trial18 that allocates 1:1 re-operation (or not) for patients with recurrent Glioblastoma. The primary outcome is overall survival. Secondary outcomes include standard peri-operative safety outcomes and (a notion of) 'quality survival', or survival at home, measured by counting days of survival minus days in hospital/nursing home/palliative care setting. Blinding is not feasible; treatment allocation will not be masked. The trial allows for pre-randomization.22 The burden of the proof of benefit is on surgery. While some patients allocated non-surgical management may still want surgery, and some patients allocated surgery may prefer non-surgical management, we feel participating patients will be better informed by the discussion around trial participation.
Hypothesis:
Patients with recurrent Glioblastoma, at the time they are considered for repeat resection, who undergo repeat resection for the GBM, will experience an increase in median overall survival from 6 to 9 months.
- Conditions
- Recurrent Glioblastoma, Glioblastoma - Category
- Being tested
- Repeat Surgical Management of Recurrent GBM
- Keywords
- rGBM, repeat GBM, recurrent high grade astrocytoma
- Medical subject headings
- Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat Surgical Management of Recurrent GBMProcedure or surgery
Routine of surgical operative management. Details of treatment will be left to local centers, and recorded in the case report form (CRF).
| Study group | Role | What they receive |
|---|---|---|
| Repeat Surgical Resection | Experimental | Standard surgical operative management according to local practices. Receives: Procedure: Repeat Surgical Management of Recurrent GBM |
| Management Without Re-operation | Active comparator | Non-surgical management with standard care according to local practices. Receives: Procedure: Repeat Surgical Management of Recurrent GBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Overall Survival
The primary outcome is time to death from any cause, starting from the time of inclusion.
Measured: Follow-up for 5 Years or until death
Secondary outcomes (5)
Total length of hospitalization / palliative care / nursing home
Measured: Follow-up for 5 Years or until death
Discharge to a location other than home
Measured: Follow-up for 5 Years or until death
Total number of days spent outside a hospital or nursing care facility.
Measured: Follow-up for 5 Years or until death
Incidence of peri-operative non-neurological complications (wound infection, CSF leaks)
Measured: Follow-up for 5 Years or until death
Incidence of new significant neurological deficits after surgery (defined as new or substantially worsened aphasia, or new weakness (MRC power < 3 in one or more limbs).
Measured: Follow-up for 5 Years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start26 Aug 2021
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Why it stopped: Insufficient patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838782
- Sponsor's protocol ID
- CC-210049
- Status last verified
- Jul 2025
- First submitted
- 4 Apr 2021
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request.
Publications
Ostrom QT, Cioffi G, Gittleman H, Patil N, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012-2016. Neuro Oncol. 2019 Nov 1;21(Suppl 5):v1-v100. doi: 10.1093/neuonc/noz150.
PubMed 31675094Thakkar JP, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, Villano JL. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol Biomarkers Prev. 2014 Oct;23(10):1985-96. doi: 10.1158/1055-9965.EPI-14-0275. Epub 2014 Jul 22.
PubMed 25053711Yahia-Cherif, M., De Witte, O., Mélot, C., & Lefranc, F. (2019). P14.56 Recurrent Glioblastomas: Should we operate a second and even a third time. Neuro-Oncology, 21(Suppl 3), iii80.
De Bonis P, Anile C, Pompucci A, Fiorentino A, Balducci M, Chiesa S, Lauriola L, Maira G, Mangiola A. The influence of surgery on recurrence pattern of glioblastoma. Clin Neurol Neurosurg. 2013 Jan;115(1):37-43. doi: 10.1016/j.clineuro.2012.04.005. Epub 2012 Apr 24.
PubMed 22537870Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PubMed 15758009Weller M, Cloughesy T, Perry JR, Wick W. Standards of care for treatment of recurrent glioblastoma--are we there yet? Neuro Oncol. 2013 Jan;15(1):4-27. doi: 10.1093/neuonc/nos273. Epub 2012 Nov 7.
PubMed 23136223Gempt J, Forschler A, Buchmann N, Pape H, Ryang YM, Krieg SM, Zimmer C, Meyer B, Ringel F. Postoperative ischemic changes following resection of newly diagnosed and recurrent gliomas and their clinical relevance. J Neurosurg. 2013 Apr;118(4):801-8. doi: 10.3171/2012.12.JNS12125. Epub 2013 Feb 1.
PubMed 23373806Barbagallo GM, Jenkinson MD, Brodbelt AR. 'Recurrent' glioblastoma multiforme, when should we reoperate? Br J Neurosurg. 2008 Jun;22(3):452-5. doi: 10.1080/02688690802182256.
PubMed 18568742Mandl ES, Dirven CM, Buis DR, Postma TJ, Vandertop WP. Repeated surgery for glioblastoma multiforme: only in combination with other salvage therapy. Surg Neurol. 2008 May;69(5):506-9; discussion 509. doi: 10.1016/j.surneu.2007.03.043. Epub 2008 Feb 8.
PubMed 18262245Chen MW, Morsy AA, Liang S, Ng WH. Re-do Craniotomy for Recurrent Grade IV Glioblastomas: Impact and Outcomes from the National Neuroscience Institute Singapore. World Neurosurg. 2016 Mar;87:439-45. doi: 10.1016/j.wneu.2015.10.051. Epub 2015 Nov 14.
PubMed 26585720Hervey-Jumper SL, Berger MS. Reoperation for recurrent high-grade glioma: a current perspective of the literature. Neurosurgery. 2014 Nov;75(5):491-9; discussion 498-9. doi: 10.1227/NEU.0000000000000486.
PubMed 24991712Franceschi E, Omuro AM, Lassman AB, Demopoulos A, Nolan C, Abrey LE. Salvage temozolomide for prior temozolomide responders. Cancer. 2005 Dec 1;104(11):2473-6. doi: 10.1002/cncr.21564.
PubMed 16270316Goldman DA, Hovinga K, Reiner AS, Esquenazi Y, Tabar V, Panageas KS. The relationship between repeat resection and overall survival in patients with glioblastoma: a time-dependent analysis. J Neurosurg. 2018 Nov 1;129(5):1231-1239. doi: 10.3171/2017.6.JNS17393. Epub 2018 Jan 5.
PubMed 29303449Lu VM, Jue TR, McDonald KL, Rovin RA. The Survival Effect of Repeat Surgery at Glioblastoma Recurrence and its Trend: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Jul;115:453-459.e3. doi: 10.1016/j.wneu.2018.04.016. Epub 2018 Apr 11.
PubMed 29654958Zhao YH, Wang ZF, Pan ZY, Peus D, Delgado-Fernandez J, Pallud J, Li ZQ. A Meta-Analysis of Survival Outcomes Following Reoperation in Recurrent Glioblastoma: Time to Consider the Timing of Reoperation. Front Neurol. 2019 Mar 26;10:286. doi: 10.3389/fneur.2019.00286. eCollection 2019.
PubMed 30984099
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Repeat Resection in Recurrent Glioblastoma (4rGBM) Trial: a Randomized Care Trial for Patients With Recurrent GBM
- ClinicalTrials.gov ID
- NCT04838782
- Acronym / sponsor ID
- CC-210049
- Conditions
- Recurrent Glioblastoma, Glioblastoma - Category
- Keywords
- rGBM, repeat GBM, recurrent high grade astrocytoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient patient population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 9 Apr 2021 (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.
Patients with recurrent Glioblastoma (GBM) are commonly presented to surgeons, along with the question of whether or not to re-resect the recurrence. There is no Level 1 evidence to support a role for repeat surgery in this context, but a multitude of observational research suggests that repeat surgery may improve quality survival. Unfortunately, these studies all suffer from selection bias.
The goal of this study is to provide a care trial context to help neurosurgeons manage patients presenting with recurrent GBM, with no additional risks, tests, or interventions than what they would normally encounter in routine care. Secondary goals include a test of the hypothesis that repeat resection can improve median overall survival, and that it can increase the number of days of survival outside of a hospital/nursing/palliative care facility.
Detailed description
Glioblastoma (GBM) is the most common malignant brain tumor (48.3% of malignant tumors).1 It has a predilection for Caucasian men with a mean age of 65.1, 2 There are approximately 13,000 new diagnoses of GBM made every year in the United States.1 Patients have an average survival of 12-15 months, with a 5-year survival rate of 6.8% despite various treatments.1 If the prognosis at the time of initial diagnosis is grim, it is even worse at the time of recurrence. Recurrence after the initial resection, which can be symptomatic or discovered on surveillance MRI imaging, occurs in nearly all patients, usually within the first year, even when the initial management is aggressive.3-6 There is no standard way to care for recurrent GBM patients and treatment may include one or more of the following: repeat surgery, radiation therapy, or second-line chemotherapy.7
Repeat surgical management carries a greater risk of wound infection and cerebrospinal fluid leak than the initial surgery, especially in patients who received radiation.8 When maximal resection was attempted at the time of the initial procedure, the second surgery is more at risk of neurological injury. Repeat surgical management often also entails a delay in the initiation of further chemotherapy, as these agents are not administered peri-operatively because of potentially deleterious effects on wound healing. Nonetheless, despite, or because of the desperate setting, patients and surgeons are often pressed to consider repeat surgery, which is performed in at least 10-30% of patients.9 Repeat surgical treatment may be more favorable with younger age (<60 years), and preoperative Karnofsky performance status (KPS) of at least 70.9 Median survival following repeat resection varies between 13-54 weeks,10, 11 but all reports suffer from the limitations of retrospective studies, the most obvious being selection bias in terms of patient age, functional status, tumor location and size.11, 12 Yet, despite favorable biases some studies report no improvement in terms of survival or quality of life.13, 14 Two recent systematic meta-analyses of case series offer conflicting conclusions about the merit of re-operation.15, 16
If the intent of repeat surgery is to improve quality and quantity of life, there is no level 1 evidence it is effective.3, 16, 17 Thus repeat surgery should be considered the experimental arm of a randomized trial designed in the best interest of the patient, being only offered as a 50% chance, always balanced by a 50% chance of being allocated non-surgical care, or a chance to escape what could turn out to be unnecessary or harmful surgery.18 For patients may be better served by being free to pursue other life priorities in the company of loved ones rather than being scheduled to endure repeat craniotomy and multiple clinical or research follow-up visits. There is sufficient community equipoise to support the conduct of such a randomized trial.19
Tria Design:
The trial is a simple, all-inclusive, prospective, multicenter, randomized care trial18 that allocates 1:1 re-operation (or not) for patients with recurrent Glioblastoma. The primary outcome is overall survival. Secondary outcomes include standard peri-operative safety outcomes and (a notion of) 'quality survival', or survival at home, measured by counting days of survival minus days in hospital/nursing home/palliative care setting. Blinding is not feasible; treatment allocation will not be masked. The trial allows for pre-randomization.22 The burden of the proof of benefit is on surgery. While some patients allocated non-surgical management may still want surgery, and some patients allocated surgery may prefer non-surgical management, we feel participating patients will be better informed by the discussion around trial participation.
Hypothesis:
Patients with recurrent Glioblastoma, at the time they are considered for repeat resection, who undergo repeat resection for the GBM, will experience an increase in median overall survival from 6 to 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeat Surgical Resection | Experimental | Procedure: Repeat Surgical Management of Recurrent GBMStandard surgical operative management according to local practices. |
| Management Without Re-operation | Active comparator | Procedure: Repeat Surgical Management of Recurrent GBMNon-surgical management with standard care according to local practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Previously histologically confirmed and surgically resected Glioblastoma
- Previous craniotomy for open tumor resection (needle biopsies alone do not count as resection)
- The attending surgeon considers re-operation may improve quality survival
Key exclusion criteria (1 listed)
- Informed consent not possible
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 |
|---|---|---|
| Repeat Surgical Management of Recurrent GBMRoutine of surgical operative management. Details of treatment will be left to local centers, and recorded in the case report form (CRF). | Procedure or surgery | Management Without Re-operation, Repeat Surgical Resection |
Primary outcome
Length of Overall Survival
Time frame: Follow-up for 5 Years or until death
The primary outcome is time to death from any cause, starting from the time of inclusion.
5 secondary outcomes
Total length of hospitalization / palliative care / nursing home
Time frame: Follow-up for 5 Years or until death
Discharge to a location other than home
Time frame: Follow-up for 5 Years or until death
Total number of days spent outside a hospital or nursing care facility.
Time frame: Follow-up for 5 Years or until death
Incidence of peri-operative non-neurological complications (wound infection, CSF leaks)
Time frame: Follow-up for 5 Years or until death
Incidence of new significant neurological deficits after surgery (defined as new or substantially worsened aphasia, or new weakness (MRC power < 3 in one or more limbs).
Time frame: Follow-up for 5 Years or until death
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 31675094Ostrom QT, Cioffi G, Gittleman H, Patil N, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012-2016. Neuro Oncol. 2019 Nov 1;21(Suppl 5):v1-v100. doi: 10.1093/neuonc/noz150.
- Background: PubMed 25053711Thakkar JP, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, Villano JL. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol Biomarkers Prev. 2014 Oct;23(10):1985-96. doi: 10.1158/1055-9965.EPI-14-0275. Epub 2014 Jul 22.
- BackgroundYahia-Cherif, M., De Witte, O., Mélot, C., & Lefranc, F. (2019). P14.56 Recurrent Glioblastomas: Should we operate a second and even a third time. Neuro-Oncology, 21(Suppl 3), iii80.
- Background: PubMed 22537870De Bonis P, Anile C, Pompucci A, Fiorentino A, Balducci M, Chiesa S, Lauriola L, Maira G, Mangiola A. The influence of surgery on recurrence pattern of glioblastoma. Clin Neurol Neurosurg. 2013 Jan;115(1):37-43. doi: 10.1016/j.clineuro.2012.04.005. Epub 2012 Apr 24.
- Background: PubMed 15758009Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Background: PubMed 23136223Weller M, Cloughesy T, Perry JR, Wick W. Standards of care for treatment of recurrent glioblastoma--are we there yet? Neuro Oncol. 2013 Jan;15(1):4-27. doi: 10.1093/neuonc/nos273. Epub 2012 Nov 7.
- Background: PubMed 23373806Gempt J, Forschler A, Buchmann N, Pape H, Ryang YM, Krieg SM, Zimmer C, Meyer B, Ringel F. Postoperative ischemic changes following resection of newly diagnosed and recurrent gliomas and their clinical relevance. J Neurosurg. 2013 Apr;118(4):801-8. doi: 10.3171/2012.12.JNS12125. Epub 2013 Feb 1.
- Background: PubMed 18568742Barbagallo GM, Jenkinson MD, Brodbelt AR. 'Recurrent' glioblastoma multiforme, when should we reoperate? Br J Neurosurg. 2008 Jun;22(3):452-5. doi: 10.1080/02688690802182256.
- Background: PubMed 18262245Mandl ES, Dirven CM, Buis DR, Postma TJ, Vandertop WP. Repeated surgery for glioblastoma multiforme: only in combination with other salvage therapy. Surg Neurol. 2008 May;69(5):506-9; discussion 509. doi: 10.1016/j.surneu.2007.03.043. Epub 2008 Feb 8.
- Background: PubMed 26585720Chen MW, Morsy AA, Liang S, Ng WH. Re-do Craniotomy for Recurrent Grade IV Glioblastomas: Impact and Outcomes from the National Neuroscience Institute Singapore. World Neurosurg. 2016 Mar;87:439-45. doi: 10.1016/j.wneu.2015.10.051. Epub 2015 Nov 14.
- Background: PubMed 24991712Hervey-Jumper SL, Berger MS. Reoperation for recurrent high-grade glioma: a current perspective of the literature. Neurosurgery. 2014 Nov;75(5):491-9; discussion 498-9. doi: 10.1227/NEU.0000000000000486.
- Background: PubMed 16270316Franceschi E, Omuro AM, Lassman AB, Demopoulos A, Nolan C, Abrey LE. Salvage temozolomide for prior temozolomide responders. Cancer. 2005 Dec 1;104(11):2473-6. doi: 10.1002/cncr.21564.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request.
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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 study testing Repeat Surgical Management of Recurrent GBM in people with Recurrent Glioblastoma and Glioblastoma - Category, run by University of Alberta at 1 site in Canada.
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 4 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: withdrawn, as of the sponsor's last update on 8 Jul 2025. 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 Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Length of Overall Survival (time frame: Follow-up for 5 Years or until death). 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 NCT04838782, which also lists 24 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 8 Jul 2025.