Back to resultsA Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases (TOMOSIBII)
Primary Purpose
Metastasis to Brain of Primary Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Whole Brain XRT 30Gy/10 fractions with
Sponsored by
About this trial
This is an interventional treatment trial for Metastasis to Brain of Primary Cancer focused on measuring 1-3 brain metastases from any primary cancer
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
Sites / Locations
- Alberta Health Services, Cross Cancer Institute
- London Regional Cancer Program of the Lawson Health Research Institute
- The Ottawa Hospital Cancer Centre
- Centre Hospitalier De L'Universite de Montreal
- McGill University Health Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Radiation Therapy Treatment
Arm Description
Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
Outcomes
Primary Outcome Measures
Overall survival
Local disease control rate at 6 months
CNS disease control rate at 6 months
Secondary Outcome Measures
Assessment of RTOG versus RECIST versus Volumetric MRI criteria
Health related quality of life
Karnofsky performance status
Mini mental status exam cognition
Acute toxicity
Late toxicity
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).
Full Information
NCT ID
NCT01543542
First Posted
February 16, 2012
Last Updated
May 5, 2016
Sponsor
Lawson Health Research Institute
Collaborators
Ontario Institute for Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT01543542
Brief Title
A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
Acronym
TOMOSIBII
Official Title
A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ontario Institute for Cancer Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis to Brain of Primary Cancer
Keywords
1-3 brain metastases from any primary cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation Therapy Treatment
Arm Type
Other
Arm Description
Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
Intervention Type
Radiation
Intervention Name(s)
Whole Brain XRT 30Gy/10 fractions with
Intervention Description
30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
At approximately end of year 4 (study completion)
Title
Local disease control rate at 6 months
Time Frame
At approximately 2.5 years
Title
CNS disease control rate at 6 months
Time Frame
At approximately 2.5 years
Secondary Outcome Measure Information:
Title
Assessment of RTOG versus RECIST versus Volumetric MRI criteria
Time Frame
At approximately end of year 4 (study completion)
Title
Health related quality of life
Time Frame
At approximately end of year 4 (study completion)
Title
Karnofsky performance status
Time Frame
AT approximately end of year 4 (study completion)
Title
Mini mental status exam cognition
Time Frame
At approximately end of year 4 (study completion)
Title
Acute toxicity
Time Frame
At approximately end of year 4 (study completion)
Title
Late toxicity
Time Frame
At approximately end of year 4 (study completion)
Title
Changes in MRI endpoints
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Rodrigues, MD, MSc
Organizational Affiliation
London Regional Cancer Program of the Lawson Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glenn Bauman, MD
Organizational Affiliation
London Regional Cancer Program of the Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Health Services, Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
London Regional Cancer Program of the Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Centre Hospitalier De L'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22436144
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.
Results Reference
derived
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A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
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