GlioblastomaGamma-GBMNCT03055208
Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma
A study testing gamma knife radiosurgery (15 Gy to 50% isodose) in people with Glioblastoma, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- gamma knife radiosurgery (15 Gy to 50% isodose)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2017to 9 May 2023
- 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
- Karnofsky performance status score ≥ 60
- histology must be glioblastoma (frozen sections during surgery)
- radiographic proof of residual tumor
- Informed consent
- adequate birth control (e.g., oral contraceptives)
Who cannot join
- any previous cranial radiotherapy
- histology inconclusive or low(er)-grade astrocytoma
- contraindications for chemo- or radiotherapy
- bleeding or clotting disorders
- contraindications for MRI or CT scans
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiotherapy University Hospital Mannheim
Mannheim, 68167
About this study
Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy).
Read the detailed description
Glioblastomas are highly malignant brain tumors that recur about 6 months after treatment. Most recurrences develop at the edge of the surgical margin and a common reason for an early recurrence of a glioblastoma is when tumors are not completely resected. This may be the case when intraoperative neuro-monitoring indicates that further resection would impair certain motor functions. Physicians can identify residual tumor in early (24-72h after surgery) postoperative MRI scans and could treat these regions. However, this treatment would not be a part of the recommended standard of care and thus, any further treatment of this areas will need a clinical trial.
The aim of this trial is to evaluate if the use of another modality to deplete these areas of residual tumor identified in early postoperative MRI scans will provide a relevant benefit in terms of progression-free survival (which means a prolongation of the time that patients do not experience a re-growth of the tumor). The modality is termed "radiosurgery", which is a non-invasive technique to delete cells without using a blade but a highly focused beam of gamma rays.
The machine that focusses these rays (like a magnifying glass that can focus light), is called 'gamma knife'. Gamma knife radiosurgery is a safe and effective treatment for a plethora of malignant and benign brain tumors and the technique is used since the 1950s and there has been a continuous improvement of precision and patient comfort up to now.
- Conditions
- Glioblastoma
- Being tested
- gamma knife radiosurgery (15 Gy to 50% isodose)
- Keywords
- Glioblastoma, Radiosurgery, Gamma Knife
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma knife radiosurgery (15 Gy to 50% isodose)Radiation
Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgery | Experimental | Following intraoperative confirmation of glioblastoma (frozen section):
Early (24-72h post surgery) stereotactic ablation (gamma knife radiosurgery) of residual tumor (defined in early postoperative T1-weighted MRI scanning with and without contrast), followed by standard-of-care therapy (chemo-radiotherapy with 60 Gy external beam radiation therapy (EBRT) and 75 mg/m2/d temozolomide, followed by adjuvant chemotherapy with 150-200 mg/m2/d/cycle temozolomide in a 5/28 days schedule). Receives: Radiation: gamma knife radiosurgery (15 Gy to 50% isodose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival Time (PFS)
PFS is defined as the time span of initial diagnosis (i.e., the day of surgery) until tumor progression is confirmed in follow-up MRI scans. All scans will be assessed using modified Response Assessment in Neuro-Oncology (RANO) criteria or until death by any cause.
Measured: 2 years
Secondary outcomes (3)
Median Overall Survival Time (OS)
OS is defined as the time span of initial diagnosis (i.e., the day of surgery) until death by any cause.
Measured: 2 years
Radiation-related (acute / early delayed / late) neurotoxicity
Assessed by regular neurological examinations
Measured: 2 years
Incidence of symptomatic radionecrosis
Assessed by serial MRI scans
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start8 Feb 2017
- Primary completion30 Mar 2020
- Study completion9 May 2023 (estimated)
Why it stopped: suspended due to low accrual rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank A. Giordano, Universitätsmedizin Mannheim
- Investigators
- Frank A Giordano, MD, Principal investigator, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055208
- Sponsor's protocol ID
- Gamma-GBM
- Acronym
- Gamma-GBM
- Status last verified
- May 2023
- First submitted
- 9 Feb 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03055208
- Acronym / sponsor ID
- Gamma-GBM / Gamma-GBM
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Radiosurgery, Gamma Knife
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: suspended due to low accrual rates
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 9 May 2023 (estimated)
- First posted
- 16 Feb 2017 (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.
Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy).
Detailed description
Glioblastomas are highly malignant brain tumors that recur about 6 months after treatment. Most recurrences develop at the edge of the surgical margin and a common reason for an early recurrence of a glioblastoma is when tumors are not completely resected. This may be the case when intraoperative neuro-monitoring indicates that further resection would impair certain motor functions. Physicians can identify residual tumor in early (24-72h after surgery) postoperative MRI scans and could treat these regions. However, this treatment would not be a part of the recommended standard of care and thus, any further treatment of this areas will need a clinical trial.
The aim of this trial is to evaluate if the use of another modality to deplete these areas of residual tumor identified in early postoperative MRI scans will provide a relevant benefit in terms of progression-free survival (which means a prolongation of the time that patients do not experience a re-growth of the tumor). The modality is termed "radiosurgery", which is a non-invasive technique to delete cells without using a blade but a highly focused beam of gamma rays.
The machine that focusses these rays (like a magnifying glass that can focus light), is called 'gamma knife'. Gamma knife radiosurgery is a safe and effective treatment for a plethora of malignant and benign brain tumors and the technique is used since the 1950s and there has been a continuous improvement of precision and patient comfort up to now.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery | Experimental | Radiation: gamma knife radiosurgery (15 Gy to 50% isodose)Following intraoperative confirmation of glioblastoma (frozen section): Early (24-72h post surgery) stereotactic ablation (gamma knife radiosurgery) of residual tumor (defined in early postoperative T1-weighted MRI scanning with and without contrast), followed by standard-of-care therapy (chemo-radiotherapy with 60 Gy external beam radiation therapy (EBRT) and 75 mg/m2/d temozolomide, followed by adjuvant chemotherapy with 150-200 mg/m2/d/cycle temozolomide in a 5/28 days schedule). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- Karnofsky performance status score ≥ 60
- histology must be glioblastoma (frozen sections during surgery)
- radiographic proof of residual tumor
- Informed consent
Key exclusion criteria (5 listed)
- any previous cranial radiotherapy
- histology inconclusive or low(er)-grade astrocytoma
- contraindications for chemo- or radiotherapy
- bleeding or clotting disorders
- contraindications for MRI or CT scans
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 |
|---|---|---|
| gamma knife radiosurgery (15 Gy to 50% isodose)Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation. | Radiation | Radiosurgery |
Primary outcome
Median Progression-Free Survival Time (PFS)
Time frame: 2 years
PFS is defined as the time span of initial diagnosis (i.e., the day of surgery) until tumor progression is confirmed in follow-up MRI scans. All scans will be assessed using modified Response Assessment in Neuro-Oncology (RANO) criteria or until death by any cause.
3 secondary outcomes
Median Overall Survival Time (OS)
Time frame: 2 years
Radiation-related (acute / early delayed / late) neurotoxicity
Time frame: 2 years
Incidence of symptomatic radionecrosis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- 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.
Frank A Giordano, MD principal investigator
University Medical Center Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamma knife radiosurgery (15 Gy to 50% isodose) in people with Glioblastoma, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 6 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: paused, as of the sponsor's last update on 11 May 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 Germany. 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?
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?
Median Progression-Free Survival Time (PFS) (time frame: 2 years). 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 11 May 2023.