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Completed

NCT Number: NCT01543542

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

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.

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Key information

Conditions

Metastasis to Brain of Primary Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alberta Health Services, Cross Cancer Institute, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Brain XRT 30Gy/10 fractions with

Radiation

30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.

Primary outcomes

  1. Overall survival

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

  2. Local disease control rate at 6 months

    Time frame: At approximately 2.5 years

  3. CNS disease control rate at 6 months

    Time frame: At approximately 2.5 years

Secondary outcomes

  1. Assessment of RTOG versus RECIST versus Volumetric MRI criteria

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

  2. Health related quality of life

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

  3. Karnofsky performance status

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

  4. Mini mental status exam cognition

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

  5. Acute toxicity

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

  6. Late toxicity

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

  7. 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).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Ontario Institute for Cancer Research

Registry information

Acronym: TOMOSIBII

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2012
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.