Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer

NCT04509648 | Active Not Recruiting

• 1 other identifier: RJBC-SHF RNI
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

regional nodal irradiation; IMRT; IMPT; internal mammary nodes irradiation; Super Hypofractionated irradiation to tumor bed boost; Super Hypofractionated irradiation for one week

Outcome Measures

Primary Outcomes (1)

• Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity

  Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicities will be assessed and recorded after the last fraction using the Common Terminology Criteria for Adverse Events (CTCAE) 3.0.

  6 months

Secondary Outcomes (7)

• Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity

  5 years

• Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale

  6 months

• Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale

  5 years

• Locoregional recurrence

  5 years

• Distant metastasis free survival (DMFS)

  5 years

Other Outcomes (4)

• Quality of Life-EORTC QLQ-C30

  6 months

• Quality of Life-EORTC BR-23

  6 months

• Quality of Life-EORTC QLQ-C30

  5 years

Study Arms (1)

Super Hypofractionated radiotherapy

EXPERIMENTAL

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.

Radiation: External Beam radiotherapy using IMRT technique

Interventions

External Beam radiotherapy using IMRT technique 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

Super Hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 40379319 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lu Cao, PhD, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor of Department of Radiation Oncology

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: January 21, 2021
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2030
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)