Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT02617043
• Lead Sponsor: Fudan University

Brief Summary

The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Female
• 18-60 years old
• Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
• Pathologically confirmed invasive breast cancer
• A pathological T1-2N0M0 tumor
• Tumor bed is labeled with Titanium clips
• Negative surgical margins
• Written informed consent.

Exclusion Criteria

• KPS<70
• Treated with neoadjuvant chemotherapy
• Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
• With severe comorbidity
• Previous breast cancer or other malignant tumor history
• Previous radiotherapy for breast or thorax
• Medical contraindication for radiotherapy
• Pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0	2 year	acute toxicity related to irradiation such as lung and skin

Secondary Outcome Measures

Name	Time	Method
acute radiation-induced toxicity assessed by CTCAE v4.0	during radiotherapy; 3months; 6 months	acute toxicity related to skin and lung
local-regional recurrence	5 years
Disease free survival	5 years
Late complications	1,2,3,4,5years
cosmetic effect measured by Harvard 4 scale evaluation system	2,3,4,5years
Overall survival Over survival	5 years

Trial Locations

Locations (1)

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