Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer
- Conditions
- Breast Cancer Female
- Registration Number
- NCT05850637
- Lead Sponsor
- Prevent Senior Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Female patient;
- Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
- Age greater than or equal to 65 years;
- Breast-conserving surgery or mastectomy with or without axillary approach
- With or without neoadjuvant or adjuvant systemic treatment
- Patients with previous thoracic irradiation;
- Patients with indication for bilateral thoracic irradiation;
- Patients with breast reconstruction with prosthesis or autologous tissue;
- Patients with compromised surgical margins after resection;
- pT1-pT2 pN0 patients undergoing radical mastectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acute toxicity Events of radiotherapy up to 3 months Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0
Late toxicity Events after 3 months of radiotherapy completion Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.
- Secondary Outcome Measures
Name Time Method Overall survival 3 years defined from the date of initiation of treatment until the patient's death
QOL (Quality of Life) changes 3 years 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.Locoregional free survival 3 years from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence
Distant free survival 3 years from the date of initiation of treatment until the date of progression of distant disease evidence
Cosmesis change week 10 and week 26 after the end of the treatment 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
Trial Locations
- Locations (1)
Instituto de Pesquisa Prevent Senior
🇧🇷São Paulo, Brazil
Instituto de Pesquisa Prevent Senior🇧🇷São Paulo, Brazil