Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer

NCT ID: NCT04509648

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2030-12-30

Brief Summary

The purpose of this trial is to investigate the toxicities and efficacy of super hypofractionated regional nodal radiotherapy (RNI) for one week in breast cancer patients treated with mastectomy or breast conserving surgery. Super hypofractionated radiotherapy will be delivered to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, over survival, distant metastasis, and quality of life.

Detailed Description

Eligible breast cancer patients will receive super hypofractionated radiotherapy of 5.2 Gy in 5 fractions within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast. The dose is prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). All patients are treated with intensity modulated radiation therapy (IMRT) technique or intensity modulated proton therapy (IMPT). The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, over survival, distant metastasis, and quality of life.

Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after RNI comparing to conventional radiotherapy and lost rate of follow up of 10%. In total 197 patients are needed to be recruited.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Super Hypofractionated radiotherapy

Patients with an indication for regional nodal irradiation will receive 5.2 Gy in 5 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk) and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast at the discretion of radiation oncologist.

Group Type: EXPERIMENTAL

External Beam radiotherapy using IMRT technique

Intervention Type: RADIATION

2600cGy/ 5 fractions / 1 weeks to ipsilateral chest wall or whole breast and regional lymph regions and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast

Interventions

External Beam radiotherapy using IMRT technique

2600cGy/ 5 fractions / 1 weeks to ipsilateral chest wall or whole breast and regional lymph regions and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Aged >18 years old
• Pathologically invasive breast cancer
• Undergoing BCS or mastectomy with reconstruction allowed, along with axillary lymph node dissection or sentinel lymph node biopsy.
• Axillary lymph node metastasis confirmed histologically (involving one or more nodes), or node-negative axilla with an indication for RNI as determined by the radiation oncologist.
• Karnofsky Performance Status scoring ≥80, and anticipative overall survival >5 years
• Surgery wound healed without infection
• Negative pathologically surgical margin
• Estrogen-receptor, Progesterone-receptor, HER-2, and Ki67 index assessment on the primary breast tumor or axillary nodes is feasible.
• Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation
• Ability to understand and willingness to participate the research and sign the consent forms

Exclusion Criteria

• Pathologically positive ipsilateral supraclavicular lymph node
• Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
• Pregnant or lactating women
• Severe non-neoplastic medical comorbidities that preclude radiation treatment (e.g., severe ischemic heart disease, arrhythmia, chronic obstructive pulmonary disease).
• History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin, Adenocarcinoma in situ of the lung and carcinoma in situ of the cervix
• simultaneous contralateral breast cancer or a prior history of ipsilateral breast cancer (including DCIS).
• Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
• Active collagen vascular disease
• Definitive pathological or radiologic evidence of distant metastatic disease
• Primary T4 tumor

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

CAOLU

Associated professor of Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu Cao, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

Xie J, Zheng S, Qi WX, Gan L, Yu B, Jiang J, Zhang J, Shi Y, Dong M, Cai G, Cai R, Xu C, Xu H, Qian X, Zhang Y, Chen M, Cao L, Chen J. One-week regimen for postoperative regional irradiation in breast cancer: the ARROW trial protocol. BMJ Open. 2025 May 15;15(5):e096677. doi: 10.1136/bmjopen-2024-096677.

Reference Type: DERIVED

PMID: 40379319 (View on PubMed)

Other Identifiers

RJBC-SHF RNI

Identifier Type: -

Identifier Source: org_study_id