Metastasis to Brain of Primary Cancer
Conditions
Keywords
1-3 brain metastases from any primary cancer
Brief summary
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.
Interventions
RADIATIONWhole Brain XRT 30Gy/10 fractions with
30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.
Sponsors
Ontario Institute for Cancer Research
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological diagnosis of primary cancer * Contrast enhanced MRI demonstrating 1-3 metastases within 6 weeks of enrollment * Age greater than or equal to 18 * Karnofsky performance status greater than or equal to 70 * Patient available for subsequent follow-up appointments and testing as well as health-related quality of life questionnaires * Anticipated survival (independent of the brain metastases) greater than 3 months * Patient informed consent obtained * Metastatic suitable for synchronous boost * Extracranial disease controlled or to be treated
Exclusion criteria
* Underlying medical condition precluding adequate follow-up * Prior cranial radiotherapy * Concurrent cytotoxic chemotherapy
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini mental status exam cognition | At approximately end of year 4 (study completion) | — |
| Acute toxicity | At approximately end of year 4 (study completion) | — |
| Assessment of RTOG versus RECIST versus Volumetric MRI criteria | At approximately end of year 4 (study completion) | — |
| Changes in MRI endpoints | Measured at baseline, and 3 months and 6 months post-treatment | 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). |
| Late toxicity | At approximately end of year 4 (study completion) | — |
| Health related quality of life | At approximately end of year 4 (study completion) | — |
| Karnofsky performance status | AT approximately end of year 4 (study completion) | — |
Countries
Canada
Outcome results
None listed