Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

Summary

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.

Conditions

• Breast Cancer
• Radiotherapy; Complications
• Effect of Radiation Therapy

Interventions

RADIATION

Entire supraclavicular lymph node radiotherapy

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.

RADIATION

Medial supraclavicular lymph node radiotherapy

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China

  collaborator OTHER

• Quanzhou First Hospital

  collaborator OTHER

• Jiangyin People's Hospital

  collaborator OTHER

• Affiliated Hospital of Jiangnan University

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Fudan University

  lead OTHER

Principal Investigators

• Zhaozhi Yang, M.D · Fudan University

• Xiaomao Guo · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-20

Primary Completion

2026-08-31

Completion

2027-08-31

Countries

• China

Study Locations