Status:
RECRUITING
Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 br...
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 bre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT04509648
Start Date
January 21 2021
End Date
December 30 2030
Last Update
April 1 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025