Shandong Cancer Hospital Affiliated to Shandong University

Study Overview
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Brief Summary
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In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.

Official Title
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Shandong Cancer Hospital Affiliated to Shandong University

Conditions
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Early-stage Breast Cancer, Breast Conserving Surgery

Intervention / Treatment
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* Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients has had breast conserving surgery age ≥ 18 and ≤ 65 years with a histological diagnosis of invasive carcinoma of the breast with pathological stage of T1-2N0-1M0 multidisciplinary decision of adjuvant WBI with a boost to the tumor bed informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: patients treated with Mastectomy Need for lymph node irradiation positive or close(≤ 1 mm) surgical margin treated with neoadjuvant chemotherapy before surgery Bilateral malignancy of the breast (synchronous or metachronous) Pregnant or breastfeeding Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HF WBI-SIB breast radiation<br>WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18) | Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost<br>* hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group<br>|
| Placebo Comparator: CF WBI-SIB breast radiation<br>WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28) | Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost<br>* hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of acute skin toxicity | To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost | 2 Weeks after the end of radiotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | To determine the local control in women with early stage breast cancer treated with accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost | From data of randomization until 60 months after the end of radiotherapy of last patients | 
| Degree of chronic skin toxicity and cosmesis after radiotherapy | To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost. | 6 months after radiotherapy | 
| Degree of chronic skin toxicity and cosmesis after radiotherapy | To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost. | 2 years after radiotherapy | 
| Degree of chronic skin toxicity and cosmesis after radiotherapy | To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost. | 5 years after radiotherapy | 
| overall survival | To determine whether the overall survival after hypo-fractionated breast radiation with concurrent boost is non-inferior to conventional fractionated radiation therapy with concurrent boost. | From date of randomization until 60 months after the end of radiotherapy of last patients |