Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer
Instituto de Pesquisa Prevent Senior
São Paulo, Brazil
Acute toxicity
Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0
Time frame: Events of radiotherapy up to 3 months
Late toxicity
Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.
Time frame: Events after 3 months of radiotherapy completion
Locoregional free survival
from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence
Time frame: 3 years
Distant free survival
from the date of initiation of treatment until the date of progression of distant disease evidence
Time frame: 3 years
Overall survival
defined from the date of initiation of treatment until the patient's death
Time frame: 3 years
Cosmesis change
was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up. 1. Excellent: When compared to the untreated breast, there is no difference or minimal difference in the size or shape of the treated breast. The breast texture is the same or slightly different. There may be thickening, scar tissue, or fluid buildup in the breast, but not enough to change the appearance. 2. Good: There is a slight difference in the size or shape of the treated breast compared to the untreated breast or compared to the original appearance of the treated breast. There may be a slight reddening or darkening of the breast. Thickening or scar tissue inside the breast causes only a slight change in shape or size. 3. Fair: Obvious difference in the size and shape of the treated breast. This change involves a quarter or less of the breast. There may be
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Time frame: week 10 and week 26 after the end of the treatment
QOL (Quality of Life) changes
was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOQ-C30 and EORTC QLQ-BR-23 scales. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: 3 years