Breast Conserving Surgery, Early-stage Breast Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONWhole Breast irradiation Plus simultaneous tumor bed Boost
hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients has had breast conserving surgery 2. age ≥ 18 and ≤ 65 years 3. with a histological diagnosis of invasive carcinoma of the breast 4. with pathological stage of T1-2N0-1M0 5. multidisciplinary decision of adjuvant WBI with a boost to the tumor bed 6. informed consent obtained, signed and dated before specific protocol procedures
Exclusion criteria
1. patients treated with Mastectomy 2. Need for lymph node irradiation 3. positive or close(≤ 1 mm) surgical margin 4. treated with neoadjuvant chemotherapy before surgery 5. Bilateral malignancy of the breast (synchronous or metachronous) 6. Pregnant or breastfeeding 7. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 8. Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of acute skin toxicity | 2 Weeks after the end of radiotherapy. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local control | From data of randomization until 60 months after the end of radiotherapy of last patients | 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 |
| Degree of chronic skin toxicity and cosmesis after radiotherapy | 6 months 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. |
| overall survival | From date of randomization until 60 months after the end of radiotherapy of last patients | 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. |
Countries
China
Contacts
Primary ContactMin Xu
Outcome results
None listed