Accelerated Partial Irradiation of the Breast: New Altered Fractionation

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 45 years or 40-44 if there isn´t any other risk factor

Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm.

Disease free margins (R0: > 2mm).

Positive and negative estrogen receptor tumors.

Disqualifiers

Multicentric and multifocal tumors, except from if it´s focal and the only risk factor.

Patients must not have undergone a neoadjuvant QT therapy.

Patients with BRCA positive mutation will be excluded.

Those patients unable or unsuitable to understand and accept the informed consent.

Trial population

Breast cancer patients that meet the inclusion criteria and none of the exclusion criteria.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

174 Participants
are grouped into 1 trial group
Group A: Experimental: APBI (Accelerated Partial Breast Irradiation)

Trial outcomes

Primary outcomes

1

Evaluate the security in terms of acute toxicity

Adverse effects due to radiotherapy

Time frame
Up to 5 years after the end of the irradiation

Secondary outcomes

1

Dose analysis in critical organs

Measurement of dose in the heart, ipsilateral and contralateral lung, ipsilateral and contralateral breast taking into account the acceptable and optimal dose limit.

Time frame
Up to 5 years after the end of the irradiation
2

Evaluate chronic toxicity

Adverse effects due to radiotherapy

Time frame
Up to 5 years after the end of the irradiation
3

Verify the incidence of locoregional tumor relapses at 2 and 5 years of follow-up

Clinical or imaged based detection of the already treated breast cancer tumor (local relapse) or the ipsilateral regional ganglionic chains: armpit, supraclavicular cavity or internal breast chain (regional relapse).

Time frame
Up to 5 years after the end of the irradiation
4

Verify the disease free survival at 2 and 5 years of follow-up

The disease free survival is the time that passes from the end of the treatment until a control is done or takes place a relapse (local or distant).

Time frame
Up to 5 years after the end of the irradiation

Other outcomes

Sponsors and contacts

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