Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

Fudan University1 site in 1 country828 target enrollmentOctober 2015

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Fudan University
Enrollment: 828
Locations: 1
Primary Endpoint: ipsilateral breast tumor recurrence
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

October 2019

Last Updated

10 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Xiaoli Yu

professor

Fudan University

Eligibility Criteria

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)