Breast Cancer
Conditions
Keywords
breast cancer patients, breast conservation surgery, hypofractionated radiotherapy
Brief summary
Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.
Interventions
RADIATIONradiotherapy
one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. KPS\>=60 2. histology confirmed invasive breast cancer 3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative) 4. surgical margins negative 5. primary tumor ≤5cm in the largest diameter 6. no internal mammary node or supraclavicular node metastases or distant metastasis 7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy 8. for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date 9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy 10. patients signed written inform consent form
Exclusion criteria
1. ductal carcinoma in situ 2. prior neoadjuvant chemotherapy 3. prior breast cancer history 4. bilateral breast cancer 5. pregnant or during lactation 6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ 7. active collagen vascular disease 8. prior neoadjuvant hormone therapy 9. immediate ipsilateral breast reconstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-breast recurrence rate | 5 year | evidence of ipsilateral breast local recurrence confirmed by histology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| regional node recurrence rate | 5 year | ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology. |
| disease-free survival | 5 year | locoregional relapse, distant relapse, death |
| overall survival | 5 year | any death |
| acute toxicity | 6 months | radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria |
| late complication | 3 -10 year | breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction |
Countries
China
Outcome results
None listed