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Metastasis to Brain of Primary CancerPhase 2TOMOSIBIINCT01543542

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

A Phase 2 study testing Whole Brain XRT 30Gy/10 fractions with in people with Metastasis to Brain of Primary Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastasis to Brain of Primary Cancer
What is being tested?
Whole Brain XRT 30Gy/10 fractions with
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
5 sitesCanada
Study dates
Apr 2010to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Patient informed consent obtained
  • Metastatic suitable for synchronous boost
  • Extracranial disease controlled or to be treated

Who cannot join

  • Underlying medical condition precluding adequate follow-up
  • Prior cranial radiotherapy
  • Concurrent cytotoxic chemotherapy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Alberta Health Services, Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program of the Lawson Health Research Institute

    London, Ontario, N6A 4L6

  • Centre Hospitalier De L'Universite de Montreal

    Montreal, Quebec, H2L 4M1

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: 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.

Being tested
Whole Brain XRT 30Gy/10 fractions with
Keywords
1-3 brain metastases from any primary cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Brain XRT 30Gy/10 fractions withRadiation

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

Study groups in NCT01543542
Study groupRoleWhat they receive
Radiation Therapy TreatmentOtherWhole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
Receives: Radiation: Whole Brain XRT 30Gy/10 fractions with

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: At approximately end of year 4 (study completion)

  2. Local disease control rate at 6 months

    Measured: At approximately 2.5 years

  3. CNS disease control rate at 6 months

    Measured: At approximately 2.5 years

Secondary outcomes (7)

  1. Assessment of RTOG versus RECIST versus Volumetric MRI criteria

    Measured: At approximately end of year 4 (study completion)

  2. Health related quality of life

    Measured: At approximately end of year 4 (study completion)

  3. Karnofsky performance status

    Measured: AT approximately end of year 4 (study completion)

  4. Mini mental status exam cognition

    Measured: At approximately end of year 4 (study completion)

  5. Acute toxicity

    Measured: At approximately end of year 4 (study completion)

  6. Late toxicity

    Measured: At approximately end of year 4 (study completion)

  7. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543542
Sponsor's protocol ID
R-10-204
Other IDs
16776
Acronym
TOMOSIBII
Status last verified
May 2016
First submitted
16 Feb 2012
Last updated
6 May 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 22436144

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Whole Brain XRT 30Gy/10 fractions with in people with Metastasis to Brain of Primary Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: At approximately end of year 4 (study completion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01543542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.

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