Brain MetastasesNCT01046123
Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases
A study testing whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy in people with Brain Metastases, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Dec 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- pathologically confirmed solid malignancy diagnosed within the past 5 years (if the original pathological cancer diagnosis is more than 5 years earlier, a biopsy to confirm metastatic relapse within the past 5 years is required)
- 1-10 brain metastases
- Maximum diameter of largest metastasis ≤ 3 cm
- KPS ≥ 70
- Patient is neurologically stable with or without corticosteroids
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- Extracranial disease well-controlled (6-month estimated median life expectancy).
- Available for regular clinical and imaging follow up
- Prior craniotomy permitted
Who cannot join
- Require craniotomy to relieve mass effect
- Previous cranial radiotherapy
- Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia.
- Chemotherapy administered within one week before radiotherapy or planned within one week after radiotherapy.
- Metastases within 0.7 cm of the optic chiasm, brainstem or optic nerves
- Brainstem metastases
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- Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission
- Multiple sclerosis
- Glomerular Filtration Rate < 60 ml/minute
- Non-small cell lung cancer with liver metastases
- Bilirubin > upper normal limit
- AST or ALT > 2X upper normal limit
- Pregnancy
- Summed volume of all metastasis PTVs > 50 cm3
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans.
This study will use a novel radiotherapy technique, called volumetric modulated arc therapy (VMAT), to treat patients with brain metastases. This technique allows delivery of both a standard radiation dose to the whole brain as well as a higher radiation dose to the brain metastases at the same time.
The study will assess the effectiveness of using VMAT in treating brain metastases, and examine its potential side-effects.
Read the detailed description
This is a Phase II prospective clinical trial. Following registration, patients will be required to undertake a baseline questionnaire assessment of daily living activities using the Modified Barthel's index, as well as cognitive assessment using MMSE.
Patients will undergo MRI scan of the brain for radiotherapy planning purposes. During radiotherapy planning and for each of the five radiotherapy fractions, patients will be immobilised in a custom fitted stereotactic mask system, to minimise head movement. During treatment, patients will have daily online setup corrections to ensure treatment accuracy.
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days. Anti-nausea and anti-inflammatory medication will be prescribed to minimise acute toxicity.
Following therapy completion, patients will be seen every 3 months for the 1st year, then every 6 months thereafter. At each clinic visit, clinicians or study investigators will monitor for toxicity from therapy, document neurologic symptoms and signs and performance status as well as Modified Barthel's index and cognitive assessment.
Patients will have contrast-enhanced MRI brain at 3 months and 1 year, and contrast-enhanced CT brain at 6 months and 9 months in the first year and every 6 months after the first year. Serum creatinine levels will be done prior to each scan to ensure safety of intravenous contrast administration.
- Conditions
- Brain Metastases
- Being tested
- whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapyRadiation
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days.
| Study group | Role | What they receive |
|---|---|---|
| Whole brain radiotherapy | Experimental | whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy Receives: Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
Measured: 3 months post treatment
Secondary outcomes (6)
1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain
Measured: 1 year post-treatment
1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain
Measured: 1 year post-treatment
Median survival
Measured: No time frame
Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment
Measured: 3 months and beyond
Time to decline in activities of daily living evaluated using the Modified Barthel index
Measured: No time frame
Time to decline in cognition evaluated with the Mini-mental state examination
Measured: No time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Nichol, British Columbia Cancer Agency
- Investigators
- Alan M Nichol, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046123
- Sponsor's protocol ID
- WHAM!
- Status last verified
- Aug 2023
- First submitted
- 7 Jan 2010
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan M, Ferguson D, Ni Mhurchu E, Yuan R, Gondara L, McKenzie M, Olson R, Thiessen B, Lalani N, Ma R, Nichol A. Patients with pretreatment leukoencephalopathy and older patients have more cognitive decline after whole brain radiotherapy. Radiat Oncol. 2020 Nov 25;15(1):271. doi: 10.1186/s13014-020-01717-x.
PubMed 33239056Nichol A, Ma R, Hsu F, Gondara L, Carolan H, Olson R, Schellenberg D, Germain F, Cheung A, Peacock M, Bergman A, Vollans E, Vellani R, McKenzie M. Volumetric Radiosurgery for 1 to 10 Brain Metastases: A Multicenter, Single-Arm, Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):312-21. doi: 10.1016/j.ijrobp.2015.10.017. Epub 2015 Oct 22.
PubMed 26678660
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
- ClinicalTrials.gov ID
- NCT01046123
- Acronym / sponsor ID
- WHAM!
- Conditions
- Brain Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Jan 2010 (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.
Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans.
This study will use a novel radiotherapy technique, called volumetric modulated arc therapy (VMAT), to treat patients with brain metastases. This technique allows delivery of both a standard radiation dose to the whole brain as well as a higher radiation dose to the brain metastases at the same time.
The study will assess the effectiveness of using VMAT in treating brain metastases, and examine its potential side-effects.
Detailed description
This is a Phase II prospective clinical trial. Following registration, patients will be required to undertake a baseline questionnaire assessment of daily living activities using the Modified Barthel's index, as well as cognitive assessment using MMSE.
Patients will undergo MRI scan of the brain for radiotherapy planning purposes. During radiotherapy planning and for each of the five radiotherapy fractions, patients will be immobilised in a custom fitted stereotactic mask system, to minimise head movement. During treatment, patients will have daily online setup corrections to ensure treatment accuracy.
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days. Anti-nausea and anti-inflammatory medication will be prescribed to minimise acute toxicity.
Following therapy completion, patients will be seen every 3 months for the 1st year, then every 6 months thereafter. At each clinic visit, clinicians or study investigators will monitor for toxicity from therapy, document neurologic symptoms and signs and performance status as well as Modified Barthel's index and cognitive assessment.
Patients will have contrast-enhanced MRI brain at 3 months and 1 year, and contrast-enhanced CT brain at 6 months and 9 months in the first year and every 6 months after the first year. Serum creatinine levels will be done prior to each scan to ensure safety of intravenous contrast administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole brain radiotherapy | Experimental | Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapywhole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18
- pathologically confirmed solid malignancy diagnosed within the past 5 years (if the original pathological cancer diagnosis is more than 5 years earlier, a biopsy to confirm metastatic relapse within the past 5 years is required)
- 1-10 brain metastases
- Maximum diameter of largest metastasis ≤ 3 cm
- KPS ≥ 70
Key exclusion criteria (14 listed)
- Require craniotomy to relieve mass effect
- Previous cranial radiotherapy
- Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia.
- Chemotherapy administered within one week before radiotherapy or planned within one week after radiotherapy.
- Metastases within 0.7 cm of the optic chiasm, brainstem or optic nerves
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 |
|---|---|---|
| whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapyPatients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days. | Radiation | Whole brain radiotherapy |
Primary outcome
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
Time frame: 3 months post treatment
6 secondary outcomes
1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain
Time frame: 1 year post-treatment
1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain
Time frame: 1 year post-treatment
Median survival
Time frame: No time frame
Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment
Time frame: 3 months and beyond
Time to decline in activities of daily living evaluated using the Modified Barthel index
Time frame: No time frame
Time to decline in cognition evaluated with the Mini-mental state examination
Time frame: No time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 33239056Chan M, Ferguson D, Ni Mhurchu E, Yuan R, Gondara L, McKenzie M, Olson R, Thiessen B, Lalani N, Ma R, Nichol A. Patients with pretreatment leukoencephalopathy and older patients have more cognitive decline after whole brain radiotherapy. Radiat Oncol. 2020 Nov 25;15(1):271. doi: 10.1186/s13014-020-01717-x.
- Derived from this study: PubMed 26678660Nichol A, Ma R, Hsu F, Gondara L, Carolan H, Olson R, Schellenberg D, Germain F, Cheung A, Peacock M, Bergman A, Vollans E, Vellani R, McKenzie M. Volumetric Radiosurgery for 1 to 10 Brain Metastases: A Multicenter, Single-Arm, Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):312-21. doi: 10.1016/j.ijrobp.2015.10.017. Epub 2015 Oct 22.
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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.
Alan M Nichol, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy in people with Brain Metastases, run by British Columbia Cancer Agency 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 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?
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?
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain (time frame: 3 months post treatment). 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 NCT01046123, which also lists 2 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 14 Aug 2023.