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

• Conditions: Breast Cancer

• Registration Number: NCT02617082
• Lead Sponsor: Fudan University

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 Timeline

• Study Start: 2015-10
• Status Verified: 2015-11
• Study First Submitted: 2015-11-21
• Study First Submitted QC: 2015-11-27
• Last Update Submitted: 2015-11-27
• Study First Posted: 2015-11-30
• Last Update Posted: 2015-11-30
• Primary Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 828

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ipsilateral breast tumor recurrence	5 years

Secondary Outcome Measures

Name	Time	Method
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
occurrence of contralateral breast tumor after PBI	5 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China