Health Trials

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

ConditionBreast Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorNational Institute of Oncology, Hungary

About this trial

To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage 0 & I & II (< 3 cm) breast carcinoma

Lesions of < 3 cm diameter

Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)

Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)

Disqualifiers

Stage III-IV breast cancer

Surgical margins that cannot be microscopically assessed

Extensive intraductal component (EIC+)

Extensive lymphovascular invasion (LVI+) (focal is allowed)

Trial design

Design model

Single group

Treatments tested in this trial

  • single-fraction very accelerated partial breast irradiation

    Radiation

    Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: single-fraction very accelerated partial breast irradiation armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Five-year incidence of late grade ≥ 2 side effects

Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).

Time frame
From the third month of treatment to the end of the fifth year of follow-up.

Secondary outcomes

1

Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR)

Time frame
From treatment to the end of the fifth year of follow-up.
2

Incidence (5-year actuarial rate) of regional relapse (RR)

Time frame
From treatment to the end of the fifth year of follow-up.
3

Incidence (5-year actuarial rate) of contralateral breast cancer (CBC)

Time frame
From treatment to the end of the fifth year of follow-up.
4

Incidence (5-year actuarial rate) of distant metastasis (DM)

Time frame
From treatment to the end of the fifth year of follow-up.

Other outcomes

Sponsors and contacts

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

National Institute of Oncology, Hungary

Lead sponsor

Source ClinicalTrials.gov
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