Status:
RECRUITING
Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
RenJi Hospital
Shanghai 10th People's Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-...
Detailed Description
Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as conventional radiotherapy in breast cancer patients with an indication for regional nodal irradiation. Eli...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Age 18-75 years old
- unilateral histologically confirmed invasive breast carcinoma of pT1-3
- breast conservation surgery or mastectomy
- Breast reconstruction is allowed
- histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection is allowed)
- Life expectancy of \>5 years
- A minimum negative surgical margin width of \>2mm
- Karnofsky Performance Status ≥80
- Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2 (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.
- Written informed consent
- Exclusion criteria:
- Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or residual axillary nodes that may be eligible for a boost dose.
- Pregnant or lactating
- Severe non-neoplastic medical comorbidities
- Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Simultaneous contralateral breast cancer
- Previous RT to thoracic and/or axillary, cervical region
- Active collagen vascular disease
- Evidence of distant metastatic disease and/or T4 disease
- Notes for exlusion criteria:
- Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that would preclude radiation treatment will be excluded.
- Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.
Exclusion
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT03829553
Start Date
February 21 2019
End Date
December 1 2027
Last Update
June 2 2022
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025