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| ID | Type | Description | Link |
|---|---|---|---|
| 16776 | Other Identifier | Research Ethics Board |
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| Name | Class |
|---|---|
| Ontario Institute for Cancer Research | OTHER |
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Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy imaging of the body. This new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. In this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. In addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy Treatment | Other | Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Brain XRT 30Gy/10 fractions with | Radiation | 30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | At approximately end of year 4 (study completion) | |
| Local disease control rate at 6 months | At approximately 2.5 years | |
| CNS disease control rate at 6 months | At approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of RTOG versus RECIST versus Volumetric MRI criteria | At approximately end of year 4 (study completion) | |
| Health related quality of life | At approximately end of year 4 (study completion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Rodrigues, MD, MSc | London Regional Cancer Program of the Lawson Health Research Institute | Principal Investigator |
| Glenn Bauman, MD | London Regional Cancer Program of the Lawson Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services, Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada | ||
| London Regional Cancer Program of the Lawson Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22436144 | Derived | Rodrigues G, Yartsev S, Tay KY, Pond GR, Lagerwaard F, Bauman G. A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases. Radiat Oncol. 2012 Mar 21;7:42. doi: 10.1186/1748-717X-7-42. |
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| Karnofsky performance status | AT approximately end of year 4 (study completion) |
| Mini mental status exam cognition | At approximately end of year 4 (study completion) |
| Acute toxicity | At approximately end of year 4 (study completion) |
| Late toxicity | At approximately end of year 4 (study completion) |
| Changes in MRI endpoints | Assessment in changes of diffusional weighted imaging and magnetic resonance spectroscopy. Changes at 3 months post-treatment and 6 months post-treatment will be compared to baseline (pre-treatment). | Measured at baseline, and 3 months and 6 months post-treatment |
| London |
| Ontario |
| N6A 4L6 |
| Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Centre Hospitalier De L'Universite de Montreal | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |