Metastasis to Brain of Primary Cancer Clinical Trial
— TOMOSIBIIOfficial title:
A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases
| Verified date | May 2016 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Alberta Health Services, Cross Cancer Institute | Edmonton | Alberta |
| Canada | London Regional Cancer Program of the Lawson Health Research Institute | London | Ontario |
| Canada | Centre Hospitalier De L'Universite de Montreal | Montreal | Quebec |
| Canada | McGill University Health Centre | Montreal | Quebec |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute | Ontario Institute for Cancer Research |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | At approximately end of year 4 (study completion) | No | |
| Primary | Local disease control rate at 6 months | At approximately 2.5 years | No | |
| Primary | CNS disease control rate at 6 months | At approximately 2.5 years | No | |
| Secondary | Assessment of RTOG versus RECIST versus Volumetric MRI criteria | At approximately end of year 4 (study completion) | No | |
| Secondary | Health related quality of life | At approximately end of year 4 (study completion) | No | |
| Secondary | Karnofsky performance status | AT approximately end of year 4 (study completion) | No | |
| Secondary | Mini mental status exam cognition | At approximately end of year 4 (study completion) | No | |
| Secondary | Acute toxicity | At approximately end of year 4 (study completion) | Yes | |
| Secondary | Late toxicity | At approximately end of year 4 (study completion) | Yes | |
| Secondary | 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 | No |