Trials / Recruiting
RecruitingNCT04669873
Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Instituto Brasileiro de Controle do Cancer · Academic / Other
- Sex
- Female
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer. There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
Detailed description
The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Active Comparator: Standard | Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks |
| RADIATION | Experimental 1: Hypofractionated radiotherapy | Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week |
| RADIATION | Experimental 2: Accelerated Partial Breast Irradiation | Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days. |
Timeline
- Start date
- 2021-03-04
- Primary completion
- 2025-12-07
- Completion
- 2026-12-31
- First posted
- 2020-12-17
- Last updated
- 2021-03-08
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04669873. Inclusion in this directory is not an endorsement.