Clinical trial · Interventional
Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer
One-week Hypofractionated Radiotherapy in Breast Cancer Patients With an Indication for Regional Nodal Irradiation: Prospective, Single-arm Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam radiotherapy using IMRT technique | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Super Hypofractionated radiotherapy
- description
- 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.
- interventionNames
- Radiation: External Beam radiotherapy using IMRT technique
Primary outcomes (1)
- measure
- Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDXie 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