Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
Recruiting · NCT07021846 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
hypofractionated radiotherapy with tumor bed boost
What this trial is about
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)
Who can take part
Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Università Campus Biomedico - Roma, Italy