The Postoperative Radiotherapy in N1 Breast Cancer Patients
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
Seoul National University Hospital
1,106 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
Summary
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
Locations(1)
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NCT05440149