aPBI Re-irradiation
ConditionBreast Cancer Recurrent
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorDartmouth-Hitchcock Medical Center
About this trial
This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
Patients must have received prior radiotherapy to the breast
Patients must have an intact, involved breast.
Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.
Disqualifiers
Patients who have not received prior radiotherapy to the ipsilateral breast.
Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation, including those who meet criteria for conditionally recommended, conditionally not recommended, and not recommended for partial breast irradiation.
Patients who are < 40 years of age.
Patients with breast implants or other breast reconstruction.
Trial design
Design model
Single group
Treatments tested in this trial
Reirradiation
RadiationaPBI, which is routinely used to treat patients who have previously not been irradiated, with a dose of 30 Gy in 5 fractions using a VMAT technique.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: aPBI Re-irradiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-associated toxicity
Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI.
Time frame
Within 1 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: