Actively Recruiting

Age: 40Years +
All Genders
NCT04101656

Accelerated Partial Irradiation of the Breast: New Altered Fractionation

Led by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Updated on 2023-11-08

174

Participants Needed

1

Research Sites

347 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.

CONDITIONS

Official Title

Accelerated Partial Irradiation of the Breast: New Altered Fractionation

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 45 years or older, or 40-44 years old without any other risk factors
  • Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) after conservative surgery
  • No lymph node involvement (pN0) of any histological degree except invasive lobular carcinoma
  • Tumor size 3 cm or smaller
  • Disease-free margins at least 2 mm (R0)
  • Estrogen receptor positive or negative tumors
Not Eligible

You will not qualify if you...

  • Multicentric and multifocal tumors, unless focal and the only risk factor
  • Prior neoadjuvant chemotherapy (QT therapy)
  • Positive BRCA mutation
  • Unable or unsuitable to understand and accept informed consent
  • Evidence of metastatic disease
  • Extensive lymphovascular invasion unless total focus and breast tissue size is 3 cm or smaller
  • Presence of breast implants in the treated breast
  • Contraindications for radiotherapy due to cutaneous lupus, pregnancy, or scleroderma
  • Inability to fully know dosimetric data of the APBI plan

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Actively Recruiting

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Research Team

C

Carlos Míguez Sánchez

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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