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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ontario Institute for Cancer Research
Information provided by (Responsible Party):
George Rodrigues, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01543542
First received: February 16, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Metastasis to Brain of Primary Cancer
Radiation: Whole Brain XRT 30Gy/10 fractions with
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Overall survival [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]
  • Local disease control rate at 6 months [ Time Frame: At approximately 2.5 years ] [ Designated as safety issue: No ]
  • CNS disease control rate at 6 months [ Time Frame: At approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of RTOG versus RECIST versus Volumetric MRI criteria [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]
  • Karnofsky performance status [ Time Frame: AT approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]
  • Mini mental status exam cognition [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: No ]
  • Acute toxicity [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: Yes ]
  • Late toxicity [ Time Frame: At approximately end of year 4 (study completion) ] [ Designated as safety issue: Yes ]
  • Changes in MRI endpoints [ Time Frame: Measured at baseline, and 3 months and 6 months post-treatment ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 93
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Radiation Therapy Treatment
Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543542

Locations
Canada, Alberta
Alberta Health Services, Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Centre Hospitalier De L'Universite de Montreal
Montreal, Quebec, Canada, H2L 4M1
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Institute for Cancer Research
Investigators
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
  More Information

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Rodrigues, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01543542     History of Changes
Other Study ID Numbers: R-10-204, 16776
Study First Received: February 16, 2012
Last Updated: May 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
1-3 brain metastases from any primary cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014