Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01543542
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : May 6, 2016
Sponsor:
Collaborator:
Ontario Institute for Cancer Research
Information provided by (Responsible Party):
George Rodrigues, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE February 16, 2012
First Posted Date  ICMJE March 5, 2012
Last Update Posted Date May 6, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • 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 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
Official Title  ICMJE A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastasis to Brain of Primary Cancer
Intervention  ICMJE Radiation: Whole 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.
Study Arms  ICMJE Radiation Therapy Treatment
Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
Intervention: Radiation: Whole Brain XRT 30Gy/10 fractions with
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
91
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2012)
93
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01543542
Other Study ID Numbers  ICMJE R-10-204
16776 ( Other Identifier: Research Ethics Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party George Rodrigues, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Ontario Institute for Cancer Research
Investigators  ICMJE
Principal Investigator: George Rodrigues, MD, MSc London Regional Cancer Program of the Lawson Health Research Institute
Principal Investigator: Glenn Bauman, MD London Regional Cancer Program of the Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP