The Prone Breast Radiation Therapy Trial
Primary Purpose
Ductal Carcinoma In Situ, Invasive Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Radiation Therapy Positioning Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Ductal Carcinoma In Situ focused on measuring DCIS, Early Stage Invasive breast cancer, Prone breast radiotherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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
Sites / Locations
- British Columbia Cancer Agency - Vancouver Island centre
- Sunnybrook Odette Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
RT Positioning Intervention: Supine
RT Positioning Intervention: Prone
Arm Description
Patient will be treated in a supine position as per standard of care/control.
Patient will be treated in the prone position.
Outcomes
Primary Outcome Measures
Moist Desquamation
Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01815476
First Posted
March 15, 2013
Last Updated
September 9, 2019
Sponsor
Toronto Sunnybrook Regional Cancer Centre
Collaborators
Canadian Breast Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01815476
Brief Title
The Prone Breast Radiation Therapy Trial
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Sunnybrook Regional Cancer Centre
Collaborators
Canadian Breast Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma In Situ, Invasive Breast Cancer
Keywords
DCIS, Early Stage Invasive breast cancer, Prone breast radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
378 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RT Positioning Intervention: Supine
Arm Type
Other
Arm Description
Patient will be treated in a supine position as per standard of care/control.
Arm Title
RT Positioning Intervention: Prone
Arm Type
Experimental
Arm Description
Patient will be treated in the prone position.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy Positioning Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Moist Desquamation
Description
Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.
Time Frame
6-8 week post-treatment.
Secondary Outcome Measure Information:
Title
Breast Pain
Description
Acute breast pain rates as measured by CTCAE 4.03 and Visual Analog Scale (VAS) during and up to 6-8 weeks post treatment.
Time Frame
6-8 week post-treatment.
Title
Radiation exposure of adjacent normal organs at risk
Description
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.
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Patient Reported Quality of life
Description
Change in health related Quality of Life as per the EORTC core QoL questionnaire QLQ-C30 and the breast cancer module QLQ-BR23.
Time Frame
Questionnaires will be completed by subjects at time of radiation simulation as baseline, in the 5th week of radiation therapy treatment (during routine review) and at 6-8 week follow-up.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Vesprini, MD MSc FRCPC
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency - Vancouver Island centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R6V5
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35616948
Citation
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.
Results Reference
derived
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The Prone Breast Radiation Therapy Trial
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