Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

Summary

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

Conditions

• Breast Cancer

Interventions

RADIATION

Hypofractionated radiotherapy

4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

RADIATION

Conventional radiotherapy

5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast

Sponsors & Collaborators

• RenJi Hospital

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

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

  collaborator OTHER

• Affiliated Hospital of Jiangnan University

  collaborator OTHER

• Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

  collaborator UNKNOWN

• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

  collaborator OTHER

• Ruijin Hospital

  lead OTHER

Principal Investigators

• Jia-Yi Chen · Ruijin Hospital

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

2019-02-21

Primary Completion

2022-12-31

Completion

2027-12-31

Countries

• China

Study Locations