Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Breast fibrosis
Overview
Brief Summary
The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients.
The main question[s] it aims to answer are:
- evaluate the rate of all grades of radiation-induced fibrosis at 4 years.
- evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)
Detailed Description
This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated RT to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die). The study population will include early breast cancer patients with younger age (< or= 50 years) and additional risk factors for local recurrence.
The primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years.
The secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically proven breast cancer who have undergone conservative surgery
- •at least 3 inserted clips
- •age: from 18 years old to 50 years
- •at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (\>25%), close margins (\<4 mm), non-hormone-sensitive disease, grading 3
- •ECOG performance status \< 2
- •adequate bone marrow (haemoglobin concentration \> 8 g/dl, white blood cell count \> 3000/mm3, platelet count \> 75000).
Exclusion Criteria
- •Previous chest radiation treatment
- •Bilateral breast cancer
- •Neoadjuvant chemotherapy
- •BMI \> 35
- •Collagen diseases
- •Pregnancy or breastfeeding
Outcomes
Primary Outcomes
Breast fibrosis
Time Frame: baseline, each year up to 4 years after radiotherapy
Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale
Secondary Outcomes
- Breast cosmesis(baseline, each year up to 4 years after radiotherapy)
- Quality of Life (QOL)(baseline, each year up to 4 years after radiotherapy)