One-week regional radiation therapy for breast cancer
One-week Hypofractionated Radiotherapy in Breast Cancer Patients With an Indication for Regional Nodal Irradiation: Prospective, Single-arm Trial
This study is testing a new one-week radiation treatment for breast cancer patients who have had surgery to see if it helps them recover better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 197 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04509648 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness and side effects of a one-week super hypofractionated regional nodal radiotherapy for breast cancer patients who have undergone mastectomy or breast-conserving surgery. Patients will receive targeted radiation to the chest wall or whole breast and regional lymph nodes using advanced techniques like intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT). The study aims to evaluate acute and late radiation-induced toxicities, locoregional recurrence, overall survival, distant metastasis, and quality of life over a follow-up period of at least five years.
Who should consider this trial
Good fit: Ideal candidates include women over 18 with pathologically invasive breast cancer who are undergoing surgery and have confirmed axillary lymph node metastasis or indications for regional nodal irradiation.
Not a fit: Patients with non-invasive breast cancer or those who do not meet the eligibility criteria, such as those with active infections or poor performance status, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce treatment duration while maintaining efficacy and minimizing side effects for breast cancer patients.
How similar studies have performed: While similar approaches have been explored, this specific method of super hypofractionated regional nodal radiotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Lu Cao, PhD, MD — Ruijin Hospital
- Study coordinator: Lu Cao, PhD, MD
- Email: caolu_163@ymail.com
- Phone: +86-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.