Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- Prevent Senior Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Acute toxicity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Acute toxicity
Time Frame: 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
Time Frame: Events after 3 months of radiotherapy completion
Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.
Secondary Outcomes
- Overall survival(3 years)
- QOL (Quality of Life) changes(3 years)
- Locoregional free survival(3 years)
- Distant free survival(3 years)
- Cosmesis change(week 10 and week 26 after the end of the treatment)