NCT02617082UnknownNot Applicable
Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Fudan University
- Enrollment
- 828
- Locations
- 1
- Primary Endpoint
- ipsilateral breast tumor recurrence
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
ipsilateral breast tumor recurrence
Time Frame: 5 years
Secondary Outcomes
- occurrence of contralateral breast tumor after PBI(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)
- Disease free survival(5 years)
- Complications(baseline，1，2，3，4，5 years)
Investigators
Xiaoli Yu
professor
Fudan University
Study Sites (1)
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