Health TrialsbyHealthPanel

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

ConditionBreast Cancer Female
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorOncology Institute of Vojvodina

About this trial

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.

The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Breast-conserving surgery

Invasive ductal carcinoma

Age ≥ 50

Tumor size ≤ 3 cm

Disqualifiers

Neoadjuvant systemic therapy

TNBC (triple-negative breast cancer)

Extensive intraductal component (EIC)

Lymphovascular invasion (LVI)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultra-fractionated WBI

    Radiation

    An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.

  • Ultra-fractionated PBI

    Radiation

    An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Partial Breast IrradiationActive comparator 1 intervention
Group B: Whole Breast IrradiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acute toxicity

Assessment of acute toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0

Time frame
1-6 months after RT
2

Late toxicity

Assessment of late toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0

Time frame
6-60 months after RT

Secondary outcomes

1

Local-regional control

Any newly suspicious skin change/s or palpable lymph node in the irradiated area that is/are pathologically proved to be locoregional tumor recurrence.

Time frame
3, 5 and 10 years
2

Disease-free survival

Disease-free survival refers to the time from adjuvant radiotherapy of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.

Time frame
3, 5 and 10 years
3

Overall Survival

Time from adjuvant radiotherapy to death.

Time frame
3, 5 and 10 years
4

Distant metastasis occurrence

The time from adjuvant radiotherapy to the occurrence of distant metastasis.

Time frame
3, 5 and 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oncology Institute of Vojvodina

Lead sponsor

Source ClinicalTrials.gov
Apply now