Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients

Summary

The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy or breast-conserving surgery.

Conditions

• Breast Cancer

Interventions

RADIATION

internal mammary nodal irradiation

chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Patients treated with breast-conserving surgery will receive tumor bed boost. Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.

RADIATION

no internal mammary nodal irradiation

chest wall/whole breast and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Tangshan People's Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Zhongnan Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• Lanzhou University First Hospital

  collaborator UNKNOWN

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Shu-lian Wang, M.D · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

• Ye-xiong Li, M.D · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-08

Primary Completion

2025-11-01

Completion

2030-05-31

Countries

• China

Study Locations