Breast CancerBIMRTNCT01537406
Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy
An observational study of Breast Cancer, run by British Columbia Cancer Agency at 2 sites in Canada.
Trial summary
The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY
- Type of treatment
- Surgery or procedure
- How many people
- 314 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to May 2013
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer subjects treated in Toronto, Ontario, or in Victoria, British Columbia that participated in The Canadian breast IMRT clinical trial between July 2003 to March 2005.
Who may be able to join
- Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study
Who cannot join
- Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R6V5
About this study
Official title: Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.
Read the detailed description
The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".
The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.
- Conditions
- Breast Cancer
- Being tested
- BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY
- Keywords
- BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPYRadiation
LONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY
What is being measured
The primary outcome is the main question the study is designed to answer.
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.
A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire
Measured: 8 years post RT
Secondary outcomes (3)
Does breast IMRT reduce the occurrence of late radiation therapy side effects
A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.
Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire
Measured: 8 years post RT
Does breast IMRT effect long term QOL
A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.
Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire
Measured: 8 Years post RT
Does IMRT effect local recurrence rates, overall and disease free survivals.
Data collection of local recurrences, overall and disease free survivals.
Measured: 8 years post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Pignol, MD, Principal investigator, Odette Cancer CentrePauline Truong, MD, Principal investigator, BCCA - Vancouver Island Cancer CentreIvo Olivotto, MD, Principal investigator, BCCA - Vancouver Island Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537406
- Sponsor's protocol ID
- BCCABreastIMRT
- Acronym
- BIMRT
- Status last verified
- Mar 2012
- First submitted
- 15 Feb 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
- ClinicalTrials.gov ID
- NCT01537406
- Acronym / sponsor ID
- BIMRT / BCCABreastIMRT
- Conditions
- Breast Cancer
- Keywords
- BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.
Detailed description
The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".
The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer subjects treated in Toronto, Ontario, or in Victoria, British Columbia that participated in The Canadian breast IMRT clinical trial between July 2003 to March 2005.
Key inclusion criteria (1 listed)
- Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study
Key exclusion criteria (1 listed)
- Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPYLONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY | Radiation | – |
Primary outcome
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.
Time frame: 8 years post RT
A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire
3 secondary outcomes
Does breast IMRT reduce the occurrence of late radiation therapy side effects
Time frame: 8 years post RT
Does breast IMRT effect long term QOL
Time frame: 8 Years post RT
Does IMRT effect local recurrence rates, overall and disease free survivals.
Time frame: 8 years post RT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Pignol, MD principal investigator
Odette Cancer Centre
Pauline Truong, MD principal investigator
BCCA - Vancouver Island Cancer Centre
Ivo Olivotto, MD principal investigator
BCCA - Vancouver Island Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by British Columbia Cancer Agency at 2 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Results are not available in the source record.
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?
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy. (time frame: 8 years post RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2012.