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The Postoperative Radiotherapy in N1 Breast Cancer Patients
Sponsor: Seoul National University Hospital
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.
Official title: The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
Key Details
Gender
FEMALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1106
Start Date
2022-08-01
Completion Date
2033-12-31
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
No PMRT for mastectomy / No regional RT for BCS
* 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.
PMRT for mastectomy / WBI + Regional RT for BCS
* 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)
Seoul National University Hospital
Seoul, Jongro-gu, South Korea