Breast CancerPhase 3IMRT-FUNCT01803139
Long Term Results of the Canadian Breast IMRT Study
A Phase 3 study testing Adjuvant breast radiotherapy in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant breast radiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2013to Jun 2014
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial
Who cannot join
- Patients declining participating to this study
- Patients unable to travel to the study site
- Patients deceased
Trial locations and contacts
2 sites in 1 country.
Pauline Truong, MD, MSc contact
Canada2 sites
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N3M5
Jean-Philippe Pignol, MD, PhD, 416 480 4998, jean-philippe.pignol@sunnybrook.ca
Eileen Rakovitch, MD, MSc
Vancouver Island Cancer Centre
Victoria, British Columbia, V8R6V5
Pauline Truong, MD, MSc, ptruong@bccancer.bc.ca
Michael Miller, MMiller2@bccancer.bc.ca
About this study
Official title: Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.
Read the detailed description
In 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast IMRT. The study showed a significant reduction moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of breast IMRT compared to standard radiotherapy.
The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. The investigators also hypothesize that there will not be differences in the local control rate or survival.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant breast radiotherapy
- Keywords
- Breast cancer radiotherapy IMRT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant breast radiotherapyDevice
Also called Intensity Modulated Radiation Therapy
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Standard breast radiotherapy | Active comparator | The treatment is planned using 2D wedges optimisation on the central CT-planning slice. Receives: Device: Adjuvant breast radiotherapy |
| Breast IMRT | Experimental | The treatment is planned 3D IMRT optimisation using all CT-planning slices. Receives: Device: Adjuvant breast radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic breast pain using Visual Analog Scale
Quantitatively patients will be asked if they have spontaneous breast pain in the treated breast during the last 6 months, and will be asked to rate its intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain).
Measured: 8 years plus or minus one year
Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)
Quantitatively pain intensity will be evaluated using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).
Measured: 8 years plus or minus one year
Chronic breast pain using the prescription of pain killer
The use of pain killer will be recorded.
Measured: 8 years plus or minus one year
Chronic breast pain using the McGill pain questionnaire
Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.
Measured: 8 years plus or minus one year
Secondary outcomes (8)
Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale
Skin and subcutaneous late radiation toxicity will be assessed by the clinical trial assistant using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer rating system for the cosmesis assessment. This scale evaluates skin discoloration and oedema comparing between breasts as no, small, moderate or large differences.
Measured: 8 years plus or minus one year
Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)
The patient's cosmesis self-report will be used as most reliable cosmetic endpoint and will use the Breast Cancer Treatment Outcome Scale (BCTOS).
Measured: 8 years plus or minus one year
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)
At time of initial treatment patient's quality of life was assessed at baseline, the last week of treatment, and 6 weeks after treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life general module (C-30) self-assessment questionnaire. The same questionnaire will be administered to ensure consistency in the quality of life assessment and enable comparisons over time for individuals and cohorts.
Measured: 8 years plus or minus one year
Skin and sub-cutaneous delayed telangiectasia
Telangiectasia will be classified into four categories of surface: none, less than 1cm2, 1 to 4 cm2 and over 4cm2.
Measured: 8 years plus or minus one year
Skin and sub-cutaneous induration
Induration will be evaluated using the Late Radiation Morbidity Scoring Scheme scale that classifies fibrosis in four grades.
Measured: 8 years plus or minus one year
Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale
Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis.
Measured: 8 years plus or minus one year
Cosmesis using digital photographs
Digital photographs will be taken of the treated and untreated breasts and will be evaluated for cosmetic results by four blinded individuals using the EORTC criteria and the consensus score will be recorded.
Measured: 8 years plus or minus one year
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)
At time of initial treatment patient's quality of life was assessed at baseline, the last week of treatment, and 6 weeks after treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life breast module (BR-23) self-assessment questionnaire. The same questionnaire will be administered to ensure consistency in the quality of life assessment and enable comparisons over time for individuals and cohorts.
Measured: 8 years plus or minus one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Pignol, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803139
- Sponsor's protocol ID
- IMRT-02
- Acronym
- IMRT-FU
- Status last verified
- Mar 2013
- First submitted
- 1 Mar 2012
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19.
PubMed 18285602
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. 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
- NCT01803139
- Acronym / sponsor ID
- IMRT-FU / IMRT-02
- Conditions
- Breast Cancer
- Keywords
- Breast cancer radiotherapy IMRT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Mar 2013 (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.
Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.
Detailed description
In 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast IMRT. The study showed a significant reduction moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of breast IMRT compared to standard radiotherapy.
The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. The investigators also hypothesize that there will not be differences in the local control rate or survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard breast radiotherapy | Active comparator | Device: Adjuvant breast radiotherapyThe treatment is planned using 2D wedges optimisation on the central CT-planning slice. |
| Breast IMRT | Experimental | Device: Adjuvant breast radiotherapyThe treatment is planned 3D IMRT optimisation using all CT-planning slices. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial
Key exclusion criteria (3 listed)
- Patients declining participating to this study
- Patients unable to travel to the study site
- Patients deceased
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 |
|---|---|---|
| Adjuvant breast radiotherapyAlso: Intensity Modulated Radiation TherapyAdjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist. | Device | Breast IMRT, Standard breast radiotherapy |
Primary outcome
Chronic breast pain using Visual Analog Scale
Time frame: 8 years plus or minus one year
Quantitatively patients will be asked if they have spontaneous breast pain in the treated breast during the last 6 months, and will be asked to rate its intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain).
Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)
Time frame: 8 years plus or minus one year
Quantitatively pain intensity will be evaluated using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).
Chronic breast pain using the prescription of pain killer
Time frame: 8 years plus or minus one year
The use of pain killer will be recorded.
Chronic breast pain using the McGill pain questionnaire
Time frame: 8 years plus or minus one year
Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.
8 secondary outcomes
Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale
Time frame: 8 years plus or minus one year
Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)
Time frame: 8 years plus or minus one year
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)
Time frame: 8 years plus or minus one year
Skin and sub-cutaneous delayed telangiectasia
Time frame: 8 years plus or minus one year
Skin and sub-cutaneous induration
Time frame: 8 years plus or minus one year
Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale
Time frame: 8 years plus or minus one year
Cosmesis using digital photographs
Time frame: 8 years plus or minus one year
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)
Time frame: 8 years plus or minus one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Results publication: PubMed 18285602Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19.
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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.
Pauline Truong, MD, MSc contact
Jean-Philippe Pignol, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant breast radiotherapy in people with Breast Cancer, run by Sunnybrook Health Sciences Centre 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 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: status not confirmed, as of the sponsor's last update on 4 Mar 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jean-Philippe Pignol, MD, PhD (416 480 4998, jean-philippe.pignol@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic breast pain using Visual Analog Scale (time frame: 8 years plus or minus one year). The study lists 4 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 NCT01803139, 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 4 Mar 2013.