Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
Phase 2
- Conditions
- Breast Cancer
- Interventions
- Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost
- Registration Number
- NCT02617043
- Lead Sponsor
- Fudan University
- Brief Summary
The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- Female
- 18-60 years old
- Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- Pathologically confirmed invasive breast cancer
- A pathological T1-2N0M0 tumor
- Tumor bed is labeled with Titanium clips
- Negative surgical margins
- Written informed consent.
Exclusion Criteria
- KPS<70
- Treated with neoadjuvant chemotherapy
- Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- With severe comorbidity
- Previous breast cancer or other malignant tumor history
- Previous radiotherapy for breast or thorax
- Medical contraindication for radiotherapy
- Pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HF-WBI hypofractionated whole breast irradiation with simultaneously integrated boost Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.
- Primary Outcome Measures
Name Time Method Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0 2 year acute toxicity related to irradiation such as lung and skin
- Secondary Outcome Measures
Name Time Method acute radiation-induced toxicity assessed by CTCAE v4.0 during radiotherapy; 3months; 6 months acute toxicity related to skin and lung
local-regional recurrence 5 years Disease free survival 5 years Late complications 1,2,3,4,5years cosmetic effect measured by Harvard 4 scale evaluation system 2,3,4,5years Overall survival Over survival 5 years
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China