Stereotactic Body Radiation Therapy for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03585621|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : May 9, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: SBRT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Sequential dose escalation design|
|Masking:||None (Open Label)|
|Official Title:||A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)|
|Actual Study Start Date :||July 17, 2018|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||July 17, 2023|
Experimental: SBRT to the Primary Breast Tumour
SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.
Each radiation treatment plan will be customized to the patient and tumour in order to deliver highly conformal, conebeam CT guided SBRT radiotherapy in 4 fractions delivered over 2-4 weeks.
Other Name: SABR
- Acute toxicity [ Time Frame: 12 weeks post treatment ]Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0
- Breast Symptom Scores [ Time Frame: 2 years post treatment ]Patient reported breast symptom scores for bleeding, discharge and odour measured on a scale from 1 (no symptoms) to 10 (worst possible/continuous symptoms) using the Visual Analogue Scale tool
- Patient Reported Quality of Life [ Time Frame: 2 years post treatment ]Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires
- Patient Reported Quality of Life [ Time Frame: 2 years post treatment ]Patient reported quality of life measured using the VES13 questionnaire.
- Patient Reported Pain Level [ Time Frame: 2 years post treatment ]Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain
- Tumour Response Rate [ Time Frame: 2 years post treatment ]Measured on follow-up MRI or CT imaging using RECIST criteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.
Primary breast and axillary surgery not recommended/performed due to any of the following:
- distant metastatic disease
- unresectable T4 disease and/or
- medically inoperable and/or
- patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.
Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease >= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy > 50% of the ipsilateral whole breast volume.
Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.
scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585621
|Contact: Danny Vesprini, MD, FRCPC||4164804806||Danny.Vesprini@sunnybrook.ca|
|Contact: Merrylee McGuffin, MSc, MRT(T)||4164806100 ext 85454||Merrylee.McGuffin@sunnybrook.ca|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Danny J Vesprini, MD, FRCPC 416-480-4806 email@example.com|
|Contact: Merrylee M McGuffin, MSc, MRT(T) 416-480-6100 ext 85454 Merrylee.McGuffin@sunnybrook.ca|
|Principal Investigator: Danny J Vesprini, MD, FRCPC|
|Sub-Investigator: Claire McCann, PhD|
|Principal Investigator:||Danny Vesprini, MD, FRCPC||Sunnybrook Health Sciences Centre, University of Toronto|
|Responsible Party:||Danny Vesprini, MD, MSc, FRCPC, Deputy Chief, Department of Radiation Oncology - Clinical Care, Toronto Sunnybrook Regional Cancer Centre|
|Other Study ID Numbers:||
|First Posted:||July 13, 2018 Key Record Dates|
|Last Update Posted:||May 9, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Site