- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04543851
CARA Treatment Pilot Study for Breast Positioning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5T 1K9
- BC Cancer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients diagnosed with completely excised stage I or II invasive breast cancer, or ductal carcinoma in situ (DCIS), who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy;
Any breast size with a skin fold of depth 1 cm or greater at the infra-mammary crease at the time of radiation treatment planning, or brassiere cup size equal to or larger than D;
Patients undergoing nodal radiotherapy are eligible if the above criteria are met;
Patients undergoing boost radiotherapy are eligible if the above criteria are met, but only if the surgical scar does not extend inferior to the nipple line of the breast;
Language is not a barrier if there are interpreters/family members to translate;
Patients having had chemotherapy are eligible for this study;
Exclusion Criteria:
Inability to give informed consent or comply with requirements of the trial;
Failure of healing of the surgical scar or significant post-operative wound infection;
Prior radiotherapy to either breast or to the chest;
Presence of significant connective tissue disease (e.g. systemic sclerosis); known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia);
Inability to return for assessment at both one week and two weeks following completion of radiotherapy;
Breast reconstruction;
Use of Mepitel® wound dressing product.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CARA positioning
Planning and Treatment using the CARA Device
|
Breast positioning to alleviate infra-mammary fold and lateral breast sag
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants for whom dose volume treatment planning constraints are not met using CARA support for breast setup
Time Frame: 12 months
|
Treatment planning dose constraints are: >=95% of the prescribed dose covering >=98% of the breast target tissue, including internal mammary chain when requested by the treating oncologist volume of ipsi-lateral lung receiving >= 20Gy should be <=35% volume of heart receiving >=25Gy should be <=5% maximum dose to any point in the body <=110% of the prescribed dose volume of breast receiving >=107% of prescribed dose should be <=22 cm^3 |
12 months
|
Number of participants having measured breast skin dose => 110% of the prescribed dose to an area of skin => 1 cm^2
Time Frame: 12 months
|
Skin dose is measured on the breast surface under the carbon fibre device using radio-chromic film. The area of skin receiving 70% of the prescribed dose up to the maximum absorbed dose is measured in 5% dose increments to an accuracy of 0.5 cm^2. If any participant receives => 110% of the prescribed dose to >=1 cm^2 area of skin, the study will be stopped. |
12 months
|
Number of participants scoring =>6 on the CTCAE Version 4.0 skin assessment
Time Frame: 12 months
|
Participants will undergo a detailed breast skin assessment at baseline, one week prior to RT completion, last week of RT, and one and two weeks post RT using the CTCAE Version 4 skin assessment scoring system as well as examination of the infra-mammary fold for any moist desquamation.
The dimensions and location of moist desquamation will be recorded.
In the event that a skin reaction of ≥ 6 (indicating ulceration, hemorrhage or necrosis) on the CTCAE V 4.0 scale is reported, the trial will be stopped.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Workflow measures
Time Frame: 12 months
|
Measured time to accomplish set up and treatment with CARA positioning
|
12 months
|
Setup reproducability
Time Frame: 12 months
|
Measure required shifts in patient position using kilo-voltage imaging
|
12 months
|
Doses to organs at risk comparison with standard of care
Time Frame: 12 months
|
Comparison of lung, heart, breast and normal tissue dose versus standard of care
|
12 months
|
Skin assessment versus skin dose
Time Frame: 12 months
|
CTCAE V4 and specific moist desquamation assessment of breast skin compared with measured skin dose-area data
|
12 months
|
Patient Reported outcome - skin reaction
Time Frame: 12 months
|
Questionnaire to assess patient reported side effects and skin reaction
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cheryl R Duzenli, PhD, BC Cancer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-02014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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