Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

Fudan University

Status

Unknown

Conditions

Breast Cancer

Treatments

Radiation: partial breast irradiation

Study type

Observational

Funder types

Other

Identifiers

NCT02617082

FDRT-BC004

Details and patient eligibility

About

This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Full 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.

Enrollment

828 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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