Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
NCT07021846 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2025-06-15
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)
Conditions
Interventions
- RADIATION
-
hypofractionated radiotherapy with tumor bed boost
hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost
Sponsors & Collaborators
-
Fondazione Policlinico Universitario Campus Bio-Medico
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-12
- Primary Completion
- 2026-03-31
- Completion
- 2030-03-31
Countries
- Italy
Study Locations
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