Breast NeoplasmsPhase 3NCT00187343
A Clinical Trial to Reduce Skin Burn Induced by Breast Radiotherapy Using Intensity Modulated Radiation Therapy (IMRT)
A Phase 3 study testing Breast IMRT in people with Breast Neoplasms, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
The purpose of this study is to determine whether the use of a 3D missing tissue compensation radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy in 25 treatments could reduce significantly the occurence rate and the degree of acute skin reaction compared to a standard wedged… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Breast IMRT
- Type of treatment
- Medical device
- How many people
- 340 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2003to Jun 2005
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A confirmed histological diagnosis of breast carcinoma or DCIS;
- Treated by breast conserving surgery;
- Adjuvant radiation to the breast only (less than 3 positive lymph nodes);
- Having a ECOG performance status of 0 or 1.
- Having signed an informed consent.
Who cannot join
- Patients treated by mastectomy;
- Bilateral breast cancer;
- Having an unhealed surgical scar (skin not closed and/or infection);
- Having had prior radiation to the same breast;
- Having active connective tissue disorder;
- Patient being pregnant.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N3M5
BC Cancer Agency-Vancouver Island Centre
Victoria, British Columbia, V8R6V5
About this study
Official title: A Phase III Study of Adjuvant Radiation Therapy in Early Breast Cancer Comparing the Use of Breast Intensity Modulated Radiation Therapy (IMRT) to Conventional Wedge Technique
The purpose of this study is to determine whether the use of a 3D missing tissue compensation radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy in 25 treatments could reduce significantly the occurence rate and the degree of acute skin reaction compared to a standard wedged irradiation technique.
Read the detailed description
- Description of the Problem: The majority of breast cancer patients are treated with breast-conserving surgery followed by radiotherapy, giving loco-regional control rates similar to mastectomy. Currently, the "standard" breast radiotherapy technique includes treatment of the entire breast with a tangential opposed pair of photon beams. The standard technique leads to significant acute skin toxicity, ranging from breast erythema to moist desquamation, in approximately 40% of patients. This toxicity may lead to interruptions in treatment delivery; may increase the risk of developing late skin toxicity including telangiectasia, skin fibrosis and chronic breast pain; and may also be associated with a significant decrease in health-related quality of life (HRQOL). Published data from dosimetric studies suggest that dose variations in excess of 10% within the breast may be the most important predictor of acute radiation-induced skin toxicity (RR = 9.7), and that dose toxicity occurs more frequently in the inframamary fold. A study performed at TSRCC shows that intensity modulated radiotherapy (IMRT) allows for significant improvements in dose homogeneity within the breast compared to standard breast radiotherapy techniques. Furthermore, the hot spot over 10% seen in the inframamary fold for patient with large breast volume is removed.
- Objectives:
- To determine if the occurence of acute skin toxicity in women receiving adjuvant breast radiation with IMRT is less frequent compared to women treated with conventional technique.
- To determine if the HRQOL scores, and specifically breast module subscale scores, in women receiving adjuvant breast radiation with IMRT is better than HRQOL scores in women receiving conventional technique.
- To perform a comparison of costs in the delivery of breast radiotherapy using IMRT to conventional technique.
- To determine if an increased acute skin toxicity translates into an increased late skin toxicity.
- Hypothesis:
We hypothesize that women receiving adjuvant breast radiation with IMRT will have significantly less acute skin toxicity and improved HRQOL compared to women treated with conventional techniques. We also hypothesize that there would not be increased cost related to IMRT compared to conventional technique.
Research plan: A Phase III randomised controled trial is planned, with blocked stratification on breast size and boost delivery. Eligible women include those who have been referred to TSRCC following breast-conserving surgery. They will be randomized to receive either a conventional technique treatment, either breast IMRT. Acute skin toxicity will be assessed weekly during radiotherapy and up to one month following completion of radiotherapy using the previously validated RTOG acute skin toxicity scale. The occurence, duration and intensity of acute skin toxicity will be compared. HRQOL will be assessed during and after irradiation, using validated EORTC instruments (EORTC QLQ-C30 and QLQ-BR23). 340 patients will be accrued in order to detect a 15% reduction in the ocurence of acute skin toxicity with IMRT using an a=0.05, b=0.80.
- Conditions
- Breast Neoplasms
- Being tested
- Breast IMRT
- Keywords
- 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.
Breast IMRTDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum skin toxicity measured weekly during the tratment and bi-weekly up to one month after the end of the treatment and complete resolution of skin reaction using the NCI common toxicity criteria version 3.0 scale
Secondary outcomes (7)
Breast localisation of maximum acute skin toxicity;
Time of onset of acute skin toxicity;
Pain assessment;
Duration of symptoms;
Factors associated with acute skin reactions;
HRQOL;
Drug prescription for skin care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Study completionJun 2005
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 NeoplasmsStudies 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
- Double blind
- Enrolment
- 340 participants
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Investigators
- Jean-Philippe PIGNOL, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187343
- Sponsor's protocol ID
- BreastIMRT
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 8 Sep 2008
- Results posted
- No
Publications
Mihai A, Rakovitch E, Sixel K, Woo T, Cardoso M, Bell C, Ruschin M, Pignol JP. Inverse vs. forward breast IMRT planning. Med Dosim. 2005 Fall;30(3):149-54. doi: 10.1016/j.meddos.2005.03.004.
PubMed 16112466
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Adjuvant Radiation Therapy in Early Breast Cancer Comparing the Use of Breast Intensity Modulated Radiation Therapy (IMRT) to Conventional Wedge Technique
- ClinicalTrials.gov ID
- NCT00187343
- Acronym / sponsor ID
- BreastIMRT
- Conditions
- Breast Neoplasms
- Keywords
- Radiotherapy, IMRT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Study start
- Sep 2003
- Study completion
- Jun 2005
- First posted
- 16 Sep 2005 (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 determine whether the use of a 3D missing tissue compensation radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy in 25 treatments could reduce significantly the occurence rate and the degree of acute skin reaction compared to a standard wedged irradiation technique.
Detailed description
- Description of the Problem: The majority of breast cancer patients are treated with breast-conserving surgery followed by radiotherapy, giving loco-regional control rates similar to mastectomy. Currently, the "standard" breast radiotherapy technique includes treatment of the entire breast with a tangential opposed pair of photon beams. The standard technique leads to significant acute skin toxicity, ranging from breast erythema to moist desquamation, in approximately 40% of patients. This toxicity may lead to interruptions in treatment delivery; may increase the risk of developing late skin toxicity including telangiectasia, skin fibrosis and chronic breast pain; and may also be associated with a significant decrease in health-related quality of life (HRQOL). Published data from dosimetric studies suggest that dose variations in excess of 10% within the breast may be the most important predictor of acute radiation-induced skin toxicity (RR = 9.7), and that dose toxicity occurs more frequently in the inframamary fold. A study performed at TSRCC shows that intensity modulated radiotherapy (IMRT) allows for significant improvements in dose homogeneity within the breast compared to standard breast radiotherapy techniques. Furthermore, the hot spot over 10% seen in the inframamary fold for patient with large breast volume is removed.
- Objectives:
- To determine if the occurence of acute skin toxicity in women receiving adjuvant breast radiation with IMRT is less frequent compared to women treated with conventional technique.
- To determine if the HRQOL scores, and specifically breast module subscale scores, in women receiving adjuvant breast radiation with IMRT is better than HRQOL scores in women receiving conventional technique.
- To perform a comparison of costs in the delivery of breast radiotherapy using IMRT to conventional technique.
- To determine if an increased acute skin toxicity translates into an increased late skin toxicity.
- Hypothesis:
We hypothesize that women receiving adjuvant breast radiation with IMRT will have significantly less acute skin toxicity and improved HRQOL compared to women treated with conventional techniques. We also hypothesize that there would not be increased cost related to IMRT compared to conventional technique.
Research plan: A Phase III randomised controled trial is planned, with blocked stratification on breast size and boost delivery. Eligible women include those who have been referred to TSRCC following breast-conserving surgery. They will be randomized to receive either a conventional technique treatment, either breast IMRT. Acute skin toxicity will be assessed weekly during radiotherapy and up to one month following completion of radiotherapy using the previously validated RTOG acute skin toxicity scale. The occurence, duration and intensity of acute skin toxicity will be compared. HRQOL will be assessed during and after irradiation, using validated EORTC instruments (EORTC QLQ-C30 and QLQ-BR23). 340 patients will be accrued in order to detect a 15% reduction in the ocurence of acute skin toxicity with IMRT using an a=0.05, b=0.80.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed histological diagnosis of breast carcinoma or DCIS;
- Treated by breast conserving surgery;
- Adjuvant radiation to the breast only (less than 3 positive lymph nodes);
- Having a ECOG performance status of 0 or 1.
- Having signed an informed consent.
Key exclusion criteria (6 listed)
- Patients treated by mastectomy;
- Bilateral breast cancer;
- Having an unhealed surgical scar (skin not closed and/or infection);
- Having had prior radiation to the same breast;
- Having active connective tissue disorder;
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 IMRT | Device | – |
Primary outcome
Maximum skin toxicity measured weekly during the tratment and bi-weekly up to one month after the end of the treatment and complete resolution of skin reaction using the NCI common toxicity criteria version 3.0 scale
7 secondary outcomes
Breast localisation of maximum acute skin toxicity;
Time of onset of acute skin toxicity;
Pain assessment;
Duration of symptoms;
Factors associated with acute skin reactions;
HRQOL;
Drug prescription for skin care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2008.
- Background: PubMed 16112466Mihai A, Rakovitch E, Sixel K, Woo T, Cardoso M, Bell C, Ruschin M, Pignol JP. Inverse vs. forward breast IMRT planning. Med Dosim. 2005 Fall;30(3):149-54. doi: 10.1016/j.meddos.2005.03.004.
- Facility informationLink provided by the sponsor.
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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, 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 Breast IMRT in people with Breast Neoplasms, 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 5 inclusion and 6 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 8 Sep 2008. 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?
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?
Maximum skin toxicity measured weekly during the tratment and bi-weekly up to one month after the end of the treatment and complete resolution of skin reaction using the NCI common toxicity criteria version 3.0 scale. 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 NCT00187343, 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 8 Sep 2008; AzTrials last refreshed its copy on 7 Nov 2026.