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RECRUITING
NCT07469267
NA

Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The RELAX trial is an open-label, multicenter, non-inferiority, randomized, phase 3 clinical trial. Multiple randomized trials have demonstrated the safety of omitting complete axillary-lymph-node dissection in patients with invasive breast cancer and limited sentinel lymph node metastases. However, the necessity and optimal extent of regional nodal irradiation remains uncertain. The aim of this study is to evaluate whether level I-II axillary irradiation is non-inferior to whole regional nodal irradiation in terms of disease-free survival in clinically node-negative breast cancer patients with 1-2 sentinel lymph node macro-metastases.

Official title: Entire Regional Nodal Irradiation vs. Level I-II Axillary Irradiation in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macro-metastases (RELAX):A Prospective, Multicenter, Randomized, Phase 3 Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1608

Start Date

2025-10-24

Completion Date

2035-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

RADIATION

Entire regional nodal irradiation

Radiation is delivered to the breast after BCS or chest wall after mastectomy, whole axillary lymph nodes (levels I-III) and supraclavicular lymph nodes. Internal mammary nodes(IMN) is optional and it is recommended to irradiate IMN when the tumor is located in the medial or central quadrant. Both hypofractionated and conventional fractionated radiation therapy are permitted: the conventional fractionated regimen is 50 Gy in 25 fractions of 2 Gy; the hypofractionated schedule is 42.56 Gy in 16 fractions of 2.66 Gy after mastectomy, or 40.05 Gy in 15 fractions of 2.67 Gy after breast-conserving surgery. Tumor bed after breast-conserving surgery is at the discretion of the treating physician, boost doses will be 10\~16 Gy in 5\~8 fractions of 2 Gy or 10.68\~16.2 Gy in 4\~6 fractions of 2.67 Gy.

RADIATION

Level I-II axillary irradiation

Radiation is delivered to the breast after BCS or chest wall after mastectomy and low axillary lymph nodes (levels I-II). Internal mammary nodes(IMN) is optional and it is recommended to irradiate IMN when the tumor is located in the medial or central quadrant. Both hypofractionated and conventional fractionated radiation therapy are permitted: the conventional fractionated regimen is 50 Gy in 25 fractions of 2 Gy; the hypofractionated schedule is 42.56 Gy in 16 fractions of 2.66 Gy after mastectomy, or 40.05 Gy in 15 fractions of 2.67 Gy after breast-conserving surgery. Tumor bed after breast-conserving surgery is at the discretion of the treating physician, boost doses will be 10\~16 Gy in 5\~8 fractions of 2 Gy or 10.68\~16.2 Gy in 4\~6 fractions of 2.67 Gy.

Locations (15)

Oncology Department, Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Department of Radiation and Medical Oncology,Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)

Changde, Hunan, China

Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university

Changsha, Hunan, China

Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University

Ningbo, Zhejiang, China