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

Breast Cancer Clinical Trial

— HF-WBI-SIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617043
• Other study ID #: FDRT-BC001
• Status: Recruiting
• Phase: Phase 2
• First received: November 19, 2015
• Last updated: May 1, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Fudan University
• Contact: Xiaoli Yu, MD
• Phone: +86 13817893133
• Email: stephanieyxl[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• hypofractionated whole breast irradiation with simultaneously integrated boost
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed

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	Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0	acute toxicity related to irradiation such as lung and skin	2 year
Secondary	acute radiation-induced toxicity assessed by CTCAE v4.0	acute toxicity related to skin and lung	during radiotherapy; 3months; 6 months
Secondary	local-regional recurrence		5 years
Secondary	Disease free survival		5 years
Secondary	Overall survival Over survival		5 years
Secondary	Late complications		1,2,3,4,5years
Secondary	cosmetic effect measured by Harvard 4 scale evaluation system		2,3,4,5years