Breast Cancer
Conditions
Keywords
breast cancer, partial breast irradiation, DCIS
Brief summary
This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
Detailed description
Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
Interventions
RADIATIONpartial breast irradiation
The prescription dose is 40.5Gy in 15 fractions in 3 weeks.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female * 18\ 65 years old * Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3) * Treated with breast conserving surgery * Tumor bed is labeled with Titanium clips * No malignancy history * ECOG score 0\ 1 * Written informed consent
Exclusion criteria
* DCIS of both breast * invasive breast cancer * Multicentric disease * Patients underwent mastectomy * Previous radiation therapy of breast * Medical contraindication for radiotherapy * Pregnant or nursing * suspicious calcification after surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ipsilateral breast tumor recurrence | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| occurrence of contralateral breast tumor after PBI | 5 years |
| Disease free survival | 5 years |
| Overall survival | 5 years |
| radiation-induced toxicity of breast assessed by CTCAE v4.0 | baseline, 3 months, 6 months, and every half year to 5 years |
| Complications | baseline，1，2，3，4，5 years |
Countries
China
Contacts
Primary ContactXiaoli Yu, MD.PhD
Backup ContactZhaozhi Yang, MD.PhD
Outcome results
None listed