Clinical trial NCT01543542: A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
Official title: A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastasis to Brain of Primary Cancer
Keywords: 1-3 brain metastases from any primary cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
First posted: 2012-03-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: At approximately end of year 4 (study completion)
measure: Local disease control rate at 6 months
timeFrame: At approximately 2.5 years
measure: CNS disease control rate at 6 months
timeFrame: At approximately 2.5 years
Secondary outcomes:
measure: Assessment of RTOG versus RECIST versus Volumetric MRI criteria
timeFrame: At approximately end of year 4 (study completion)
measure: Health related quality of life
timeFrame: At approximately end of year 4 (study completion)
measure: Karnofsky performance status
timeFrame: AT approximately end of year 4 (study completion)
measure: Mini mental status exam cognition
timeFrame: At approximately end of year 4 (study completion)
measure: Acute toxicity
timeFrame: At approximately end of year 4 (study completion)
measure: Late toxicity
timeFrame: At approximately end of year 4 (study completion)
measure: Changes in MRI endpoints
timeFrame: Measured at baseline, and 3 months and 6 months post-treatment
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Health Services, Cross Cancer Institute
state: Alberta
city: London
country: Canada
facility: London Regional Cancer Program of the Lawson Health Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier De L'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: London Regional Cancer Program of the Lawson Health Research Institute
name: George Rodrigues, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: London Regional Cancer Program of the Lawson Health Research Institute
name: Glenn Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.