Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University
About this trial
Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.
Eligibility criteria
Qualifiers
ECOG 0-1
Newly diagnosed invasive breast cancer
Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administered：clinical stage III or pathological stage is T1-4N1-3a/bM0.
Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with ≥10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon.
Disqualifiers
Initinal clinical diagnosis N3c (supraclavicualr node metastasis)
T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy
Distant metastasis
Bilateral breast cancer or previously contralateral breast cancer
Trial design
Treatments tested in this trial
- Entire supraclavicular lymph node radiotherapy
- Medial supraclavicular lymph node radiotherapy
Treatment groups
1,650 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fudan University
Lead sponsor
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
Quanzhou First Hospital
Collaborator
Jiangyin People's Hospital
Collaborator
Affiliated Hospital of Jiangnan University
Collaborator
Guizhou Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov