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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617082
• Other study ID #: FDRT-BC004
• Status: Recruiting
• Phase: Phase 2
• First received: November 21, 2015
• Last updated: November 27, 2015
• Start date: October 2015

Study information

• Verified date: November 2015
• Source: Fudan University
• Contact: Xiaoli Yu, MD.PhD
• Phone: +86 18017312388
• Email: stephanieyxl[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 828
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Radiation:
• partial breast irradiation
The prescription dose is 40.5Gy in 15 fractions in 3 weeks.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ipsilateral breast tumor recurrence		5 years	No
Secondary	occurrence of contralateral breast tumor after PBI		5 years	Yes
Secondary	Disease free survival		5 years	No
Secondary	Overall survival		5 years	No
Secondary	radiation-induced toxicity of breast assessed by CTCAE v4.0		baseline, 3 months, 6 months, and every half year to 5 years	No
Secondary	Complications		baseline,1,2,3,4,5 years	Yes