A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastasis to Brain of Primary Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Alberta Health Services, Cross Cancer Institute

Edmonton, Alberta, Canada

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Centre Hospitalier De L'Universite de Montreal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Overall survival

Time frame: At approximately end of year 4 (study completion)

Local disease control rate at 6 months

Time frame: At approximately 2.5 years

CNS disease control rate at 6 months

Time frame: At approximately 2.5 years

Secondary Outcomes

Assessment of RTOG versus RECIST versus Volumetric MRI criteria

Time frame: At approximately end of year 4 (study completion)

Health related quality of life

Time frame: At approximately end of year 4 (study completion)

Karnofsky performance status

Time frame: AT approximately end of year 4 (study completion)

Mini mental status exam cognition

Time frame: At approximately end of year 4 (study completion)

Acute toxicity

Time frame: At approximately end of year 4 (study completion)

Late toxicity

Time frame: 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).

Time frame: Measured at baseline, and 3 months and 6 months post-treatment