Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial
Fondazione Policlinico Universitario Campus Bio-Medico
132 participants
Mar 12, 2020
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria6
- 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 Criteria6
- Previous chest radiation treatment
- Bilateral breast cancer
- Neoadjuvant chemotherapy
- BMI \> 35
- Collagen diseases
- Pregnancy or breastfeeding
Interventions
hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07021846