Glioblastoma MutliformeNCT01702610
Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
A study testing IMRT Technique, IMRT and accelerated hypofractionation technique and neo-adjuvant TMZ followed by accelerated hypofractionated EBRT in people with Glioblastoma Mutliforme, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Mutliforme
- What is being tested?
- IMRT Technique, IMRT and accelerated hypofractionation technique and neo-adjuvant TMZ followed by accelerated hypofractionated EBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Dec 2014
- 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 years or older
- Histological confirmation of supratentorial GBM
- KPS > 60
- Neurological function 0 or 1
- Adequate bone marrow as defined below:
- absolute neutrophil count (ANC) > 1500 cells/mm3
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- platelets > 100,000 cells/mm3
- hemoglobin > 10g/dl
- Adequate renal function as defined below:
- BUN < 25mg/dl within 14 days prior to study registration
- creatinine of 63 to 103 umol/L within 14 days prior to study registration
- Adequate hepatic function as defined below:
- Bilirubin of 3 to 21 umol/L within 14 days prior to study registration
- ALT \& AST < 3xnormal range within 14 days prior to study registration
- Neoadjuvant TMZ to start within 3 weeks of surgery/biopsy if no resection was deemed feasible
- A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively.
- History, physical and neurological examination within 14 days prior to study registration.
- For females of child-bearing potential, negative pregnancy test within 72 hours prior to starting TMZ.
- Able to sign an informed study-specific consent
Who cannot join
- Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or optic nerves.
- Prior invasive malignancy, unless disease-free for >3years
- Recurrent or multifocal GBM
- Severe co-morbidities such as
- unstable angina
- transmural myocardial infarction within 6 months
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- COPD at the time of registration
- Hepatic insufficiency
- Bacterial or fungal infection requiring IV antibiotics at the time of registration
- Acquired Immune Deficiency Syndrome (AIDS)
- Major medical illnesses or psychiatric impairments
- Pregnant women or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.
Read the detailed description
In this proposal, the total cumulative dose of TMZ is unchanged as compared to the doses used in the Stupp protocol. In this proposal, the dose of TMZ is the same, with the sole difference that TMZ will be given in a neo-adjuvant setting for two weeks and then continued at the same dose concurrently with the accelerated hypofractionated EBRT delivering 60Gy in 4 weeks. The adjuvant component of TMZ remains unchanged from current standard practice.
- Conditions
- Glioblastoma Mutliforme
- Being tested
- IMRT Technique, IMRT and accelerated hypofractionation technique, neo-adjuvant TMZ followed by accelerated hypofractionated EBRT, Temozolomide and Accelerated Hypofractionation RT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT TechniqueRadiation
IMRT and accelerated hypofractionation techniqueRadiation
Intervention is the technique and accelerated fractionation used to treat GBM
neo-adjuvant TMZ followed by accelerated hypofractionated EBRTRadiation
Two weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component
Temozolomide and Accelerated Hypofractionation RTDrug
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide, Accelerated Hypofractionated RT | Experimental | Patient will receive two weeks of neo-adjuvant Temozolomide followed by Accelerated Hypofractionated RT for a total of 20 fractions for a total of 60Gy followed by Temozolomide for 12 cycles. Receives: Radiation: IMRT Technique; Radiation: IMRT and accelerated hypofractionation technique; Radiation: neo-adjuvant TMZ followed by accelerated hypofractionated EBRT; Drug: Temozolomide and Accelerated Hypofractionation RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients completing the study treatment
To determine overall survival.
Measured: At one year
To assess toxicity of the regimen
Toxicity will be assessed and graded according to CTCAE-V3
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startDec 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MutliformeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Shenouda, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702610
- Sponsor's protocol ID
- GEN-08-013
- Other IDs
- MGRT01:TMZ/GBM
- Status last verified
- Sep 2016
- First submitted
- 22 Aug 2012
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shenouda G, Souhami L, Petrecca K, Owen S, Panet-Raymond V, Guiot MC, Corredor AG, Abdulkarim B. A Phase 2 Trial of Neoadjuvant Temozolomide Followed by Hypofractionated Accelerated Radiation Therapy With Concurrent and Adjuvant Temozolomide for Patients With Glioblastoma. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):487-494. doi: 10.1016/j.ijrobp.2016.11.006. Epub 2016 Nov 15.
PubMed 28011051
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01702610
- Acronym / sponsor ID
- GEN-08-013
- Conditions
- Glioblastoma Mutliforme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2012 (estimated)
- 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 GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.
Detailed description
In this proposal, the total cumulative dose of TMZ is unchanged as compared to the doses used in the Stupp protocol. In this proposal, the dose of TMZ is the same, with the sole difference that TMZ will be given in a neo-adjuvant setting for two weeks and then continued at the same dose concurrently with the accelerated hypofractionated EBRT delivering 60Gy in 4 weeks. The adjuvant component of TMZ remains unchanged from current standard practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide, Accelerated Hypofractionated RT | Experimental | Radiation: IMRT Technique, Radiation: IMRT and accelerated hypofractionation technique, Radiation: neo-adjuvant TMZ followed by accelerated hypofractionated EBRT, Drug: Temozolomide and Accelerated Hypofractionation RTPatient will receive two weeks of neo-adjuvant Temozolomide followed by Accelerated Hypofractionated RT for a total of 20 fractions for a total of 60Gy followed by Temozolomide for 12 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age: 18 years or older
- Histological confirmation of supratentorial GBM
- KPS > 60
- Neurological function 0 or 1
- Adequate bone marrow as defined below:
Key exclusion criteria (12 listed)
- Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or optic nerves.
- Prior invasive malignancy, unless disease-free for >3years
- Recurrent or multifocal GBM
- Severe co-morbidities such as
- unstable angina
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 |
|---|---|---|
| IMRT Technique | Radiation | Temozolomide, Accelerated Hypofractionated RT |
| IMRT and accelerated hypofractionation techniqueIntervention is the technique and accelerated fractionation used to treat GBM | Radiation | Temozolomide, Accelerated Hypofractionated RT |
| neo-adjuvant TMZ followed by accelerated hypofractionated EBRTTwo weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component | Radiation | Temozolomide, Accelerated Hypofractionated RT |
| Temozolomide and Accelerated Hypofractionation RT | Drug | Temozolomide, Accelerated Hypofractionated RT |
Primary outcome
Percent of patients completing the study treatment
Time frame: At one year
To determine overall survival.
To assess toxicity of the regimen
Time frame: At one year
Toxicity will be assessed and graded according to CTCAE-V3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 28011051Shenouda G, Souhami L, Petrecca K, Owen S, Panet-Raymond V, Guiot MC, Corredor AG, Abdulkarim B. A Phase 2 Trial of Neoadjuvant Temozolomide Followed by Hypofractionated Accelerated Radiation Therapy With Concurrent and Adjuvant Temozolomide for Patients With Glioblastoma. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):487-494. doi: 10.1016/j.ijrobp.2016.11.006. Epub 2016 Nov 15.
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 IMRT Technique, IMRT and accelerated hypofractionation technique and neo-adjuvant TMZ followed by accelerated hypofractionated EBRT in people with Glioblastoma Mutliforme, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 19 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: finished, as of the sponsor's last update on 28 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of patients completing the study treatment (time frame: At one year). The study lists 2 primary outcomes in all. 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 NCT01702610, which also lists 1 linked publication.
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 28 Sep 2016.