GlioblastomaPhase 2NCT02206230
Trial of Hypofractionated Radiation Therapy for Glioblastoma
A Phase 2 study testing Hypofractionated radiation therapy and Standard radiation therapy in people with Glioblastoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Hypofractionated radiation therapy and Standard radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2014to 14 Feb 2023
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed, histologically proven, intracranial glioblastoma or gliosarcoma treated with maximal safe resection, which may be biopsy alone if resection is not possible.
- History and physical examination, including neurological examination, within 14 days prior to randomization.
- Age between 18 and 70 years, inclusive.
- ECOG performance score 0-2.
- Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization (Stupp et al.).
- Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below: (Stupp et al.)
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- ANC ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Serum creatinine ≤ 1.5 times ULN
- Total serum bilirubin ≤ 1.5 times ULN
- ALT < 3 times ULN
- AST < 3 times ULN
- Alkaline phosphatase < 3 times ULN
- Patients must sign a study-specific informed consent prior to study registration and must be willing to comply with study treatment, questionnaire completion and follow-up.
Who cannot join
- Recurrent or multifocal malignant gliomas. Multicentric gliomas, defined as multiple, discrete areas of enhancement on T1 weighted MRI sequences with contrast all contained within one connected region of abnormality on T2 weighted/FLAIR MRI sequences, are allowed to enroll on this study.
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless expected survival from prior malignancy is ≥ 5 years.
- Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
- Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization
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- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration
- Any severe, active co-morbidity precluding delivery of temozolomide.
- Women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to temozolomide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma
This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma
Read the detailed description
Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 - 70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the length of the radiation course required for these patients with limited survival. The importance of hypofractionation is, therefore, not in improving survival, but rather to shorten RT duration to improve patient comfort and convenience. This approach is pertinent given the limited life expectancy of glioblastoma and has been used in patients with prolonged survival including breast and prostate cancers.
- Conditions
- Glioblastoma
- Being tested
- Hypofractionated radiation therapy, Standard radiation therapy
- Keywords
- glioblastoma, radiotherapy, hypofractionated radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiation therapyRadiation
Standard radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiation therapy | Experimental | Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6-12 cycles(as per institutional standard).. Receives: Radiation: Hypofractionated radiation therapy |
| Standard radiation therapy | Active comparator | Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6-12 cycles(as per institutional standard).. Receives: Radiation: Standard radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
defined as the time between randomization and death due to any cause.
Measured: Patients without an event will be censored the last time they were known to be alive. Median, 6-month, 1-year, and 2-year OS rates will be measured.
Secondary outcomes (3)
Progression-free survival (PFS)
defined as the time between randomization and radiographic progression based on RECIST criteria (see section 4.5) or clinical progression leading to institution or change in radiation or systemic therapy for progressive or recurrent disease or death due to any cause.
Measured: Patients without an event will be censored at date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at day of randomization. Median, 6-month, 1-yr, and 2-yr PFS rates will be measured
Adverse events according to NCI CTCAE version 4.0 criteria.
Adverse events will be reported as listings and summarized as frequency tables. Additional reports by grade, causality, and relationship to study treatment will be produced. Incidence of adverse events by stratification variables will be assessed
Measured: Evaluated weekly during radiation therapy; on C1D1 and at the end of every 2 cycles of adjuvant temozolomide; post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative
Health-related quality-of-life as assessed by MMSE and EORTC QLQ-C30/QLQ-BN20 questionnaires.
Kaplan-Meier curves and estimates of median time to event, and corresponding 95% confidence intervals, for each health-related quality-of-life scale (overall score of MMSE and each measure on EORTC QLQ-C30/QLQ-BN20 questionnaires) will be assessed. The difference in health-related quality-of-life between the treatment arms will be determined with a stratified log-rank test at the 5% alpha level
Measured: Evaluated at baseline, weekly during radiation therapy, at the end of every 2 cycles of adjuvant temozolomide, and post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study start25 Sep 2014
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1, randomized, open label
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Samir Patel, MD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206230
- Sponsor's protocol ID
- BR-02-1401
- Status last verified
- Jan 2024
- First submitted
- 24 Jul 2014
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang F, Dinakaran D, Heikal AA, Yaghoobpour Tari S, Ghosh S, Amanie J, Murtha A, Rowe LS, Roa WH, Patel S. Dosimetric predictors of toxicity in a randomized study of short-course vs conventional radiotherapy for glioblastoma. Radiother Oncol. 2022 Dec;177:152-157. doi: 10.1016/j.radonc.2022.10.016. Epub 2022 Oct 20.
PubMed 36273738
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT02206230
- Acronym / sponsor ID
- BR-02-1401
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, radiotherapy, hypofractionated radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- 25 Sep 2014 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 1 Aug 2014 (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.
This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma
Detailed description
Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 - 70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the length of the radiation course required for these patients with limited survival. The importance of hypofractionation is, therefore, not in improving survival, but rather to shorten RT duration to improve patient comfort and convenience. This approach is pertinent given the limited life expectancy of glioblastoma and has been used in patients with prolonged survival including breast and prostate cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1, randomized, open label
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiation therapy | Experimental | Radiation: Hypofractionated radiation therapyHypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6-12 cycles(as per institutional standard).. |
| Standard radiation therapy | Active comparator | Radiation: Standard radiation therapyStandard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6-12 cycles(as per institutional standard).. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Newly-diagnosed, histologically proven, intracranial glioblastoma or gliosarcoma treated with maximal safe resection, which may be biopsy alone if resection is not possible.
- History and physical examination, including neurological examination, within 14 days prior to randomization.
- Age between 18 and 70 years, inclusive.
- ECOG performance score 0-2.
- Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization (Stupp et al.).
Key exclusion criteria (11 listed)
- Recurrent or multifocal malignant gliomas. Multicentric gliomas, defined as multiple, discrete areas of enhancement on T1 weighted MRI sequences with contrast all contained within one connected region of abnormality on T2 weighted/FLAIR MRI sequences, are allowed to enroll on this study.
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless expected survival from prior malignancy is ≥ 5 years.
- Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
- Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.
- Severe, active co-morbidity, defined as follows:
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 |
|---|---|---|
| Hypofractionated radiation therapy | Radiation | Hypofractionated radiation therapy |
| Standard radiation therapy | Radiation | Standard radiation therapy |
Primary outcome
Overall survival
Time frame: Patients without an event will be censored the last time they were known to be alive. Median, 6-month, 1-year, and 2-year OS rates will be measured.
defined as the time between randomization and death due to any cause.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Patients without an event will be censored at date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at day of randomization. Median, 6-month, 1-yr, and 2-yr PFS rates will be measured
Adverse events according to NCI CTCAE version 4.0 criteria.
Time frame: Evaluated weekly during radiation therapy; on C1D1 and at the end of every 2 cycles of adjuvant temozolomide; post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative
Health-related quality-of-life as assessed by MMSE and EORTC QLQ-C30/QLQ-BN20 questionnaires.
Time frame: Evaluated at baseline, weekly during radiation therapy, at the end of every 2 cycles of adjuvant temozolomide, and post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative
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 31 Jan 2024.
- Derived from this study: PubMed 36273738Yang F, Dinakaran D, Heikal AA, Yaghoobpour Tari S, Ghosh S, Amanie J, Murtha A, Rowe LS, Roa WH, Patel S. Dosimetric predictors of toxicity in a randomized study of short-course vs conventional radiotherapy for glioblastoma. Radiother Oncol. 2022 Dec;177:152-157. doi: 10.1016/j.radonc.2022.10.016. Epub 2022 Oct 20.
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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.
Samir Patel, MD principal investigator
Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated radiation therapy and Standard radiation therapy in people with Glioblastoma, run by AHS Cancer Control 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 14 inclusion and 11 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 31 Jan 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall survival (time frame: Patients without an event will be censored the last time they were known to be alive. Median, 6-month, 1-year, and 2-year OS rates will be measured.). 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 NCT02206230, 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 31 Jan 2024.