This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Acute toxicity
Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0
Time frame: 12 weeks post treatment
Breast Symptom Scores
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
Time frame: 2 years post treatment
Patient Reported Quality of Life
Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires
Time frame: 2 years post treatment
Patient Reported Quality of Life
Patient reported quality of life measured using the VES13 questionnaire.
Time frame: 2 years post treatment
Patient Reported Pain Level
Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain
Time frame: 2 years post treatment
Tumour Response Rate
Measured on follow-up MRI or CT imaging using RECIST criteria
Time frame: 2 years post treatment
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