Ductal Carcinoma In SituNCT01815476
The Prone Breast Radiation Therapy Trial
A study testing Radiation Therapy Positioning Intervention in people with Ductal Carcinoma In Situ and Invasive Breast Cancer, run by Toronto Sunnybrook Regional Cancer Centre at 2 sites in Canada.
Trial summary
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ductal Carcinoma In Situ, Invasive Breast Cancer
- What is being tested?
- Radiation Therapy Positioning Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 2 sitesCanada
- Study dates
- 4 May 2013to Jun 2019
- Phase
- Interventional
- 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
- confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
- treated with BCT;
- no indication for treatment of regional LN;
- Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater
Who cannot join
- Regional Lymph Node XRT indicated;
- Bilateral breast cancer;
- unhealed wound (skin not closed and/or infection);
- previous XRT to the same breast;
- unable to lie prone;
- presence of active connective tissue disease;
Show all 9Show fewer
- pregnancy;
- unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy > 10%);
- adequate coverage of postoperative tumour bed not technically possible
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
British Columbia Cancer Agency - Vancouver Island centre
Victoria, British Columbia, V8R6V5
About this study
Official title: A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.
After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.
This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.
Read the detailed description
The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.
- Conditions
- Ductal Carcinoma In Situ, Invasive Breast Cancer
- Being tested
- Radiation Therapy Positioning Intervention
- Keywords
- DCIS, Early Stage Invasive breast cancer, Prone breast radiotherapy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Therapy Positioning InterventionRadiation
All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.
| Study group | Role | What they receive |
|---|---|---|
| RT Positioning Intervention: Supine | Other | Patient will be treated in a supine position as per standard of care/control. Receives: Radiation: Radiation Therapy Positioning Intervention |
| RT Positioning Intervention: Prone | Experimental | Patient will be treated in the prone position. Receives: Radiation: Radiation Therapy Positioning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moist Desquamation
Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.
Measured: 6-8 week post-treatment.
Secondary outcomes (2)
Breast Pain
Acute breast pain rates as measured by CTCAE 4.03 and Visual Analog Scale (VAS) during and up to 6-8 weeks post treatment.
Measured: 6-8 week post-treatment.
Radiation exposure of adjacent normal organs at risk
Determine if adjuvant breast IMRT in the prone position produces improved dose distribution in regards to exposure to critical structures including heart, lung, liver and contralateral breast when compared to treatment in the supine position.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study start4 May 2013
- Primary completionApr 2018
- Study completionJun 2019
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 Ductal Carcinoma In SituStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Sunnybrook Regional Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Principal investigator, Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre
- Investigators
- Danny Vesprini, MD MSc FRCPC, Principal investigator, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815476
- Sponsor's protocol ID
- 380-2012
- Status last verified
- Sep 2019
- First submitted
- 15 Mar 2013
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vesprini D, Davidson M, Bosnic S, Truong P, Vallieres I, Fenkell L, Comsa D, El-Mallah M, Garcia L, Stevens C, Nakonechny K, Tran W, Kiss A, Rakovitch E, Pignol JP. Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):994-1000. doi: 10.1001/jamaoncol.2022.1479.
PubMed 35616948
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial
- ClinicalTrials.gov ID
- NCT01815476
- Acronym / sponsor ID
- 380-2012
- Conditions
- Ductal Carcinoma In Situ, Invasive Breast Cancer
- Keywords
- DCIS, Early Stage Invasive breast cancer, Prone breast radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Toronto Sunnybrook Regional Cancer CentreUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- 4 May 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 21 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.
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.
After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.
This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.
Detailed description
The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT Positioning Intervention: Supine | Other | Radiation: Radiation Therapy Positioning InterventionPatient will be treated in a supine position as per standard of care/control. |
| RT Positioning Intervention: Prone | Experimental | Radiation: Radiation Therapy Positioning InterventionPatient will be treated in the prone position. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
- treated with BCT;
- no indication for treatment of regional LN;
- Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater
Key exclusion criteria (9 listed)
- Regional Lymph Node XRT indicated;
- Bilateral breast cancer;
- unhealed wound (skin not closed and/or infection);
- previous XRT to the same breast;
- unable to lie prone;
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 |
|---|---|---|
| Radiation Therapy Positioning InterventionAll participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms. | Radiation | RT Positioning Intervention: Prone, RT Positioning Intervention: Supine |
Primary outcome
Moist Desquamation
Time frame: 6-8 week post-treatment.
Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.
2 secondary outcomes
Breast Pain
Time frame: 6-8 week post-treatment.
Radiation exposure of adjacent normal organs at risk
Time frame: Day 1
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 11 Sep 2019.
- Derived from this study: PubMed 35616948Vesprini D, Davidson M, Bosnic S, Truong P, Vallieres I, Fenkell L, Comsa D, El-Mallah M, Garcia L, Stevens C, Nakonechny K, Tran W, Kiss A, Rakovitch E, Pignol JP. Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):994-1000. doi: 10.1001/jamaoncol.2022.1479.
Related trials for Ductal Carcinoma In Situ
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
RecruitingPhase 2
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Ductal Carcinoma in Situ
Active, not recruiting
Intraoperative Radiation Therapy (IORT) in DCIS
Breast Cancer, Ductal Carcinoma in Situ
RecruitingPhase 1
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Ductal Carcinoma in Situ
Active, not recruiting
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Mammary Tumor, Nipple Discharge
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.
Danny Vesprini, MD MSc FRCPC principal investigator
Toronto Sunnybrook Regional Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy Positioning Intervention in people with Ductal Carcinoma In Situ and Invasive Breast Cancer, run by Toronto Sunnybrook Regional Cancer 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 4 inclusion and 9 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 11 Sep 2019. 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?
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?
Moist Desquamation (time frame: 6-8 week post-treatment.). 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 NCT01815476, 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 11 Sep 2019.