Back to resultsHypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery (HF-WBI-SIB)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hypofractionated whole breast irradiation with simultaneously integrated boost
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, hypofractionated whole breast irradiation
Eligibility Criteria
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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HF-WBI
Arm Description
Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.
Outcomes
Primary Outcome Measures
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
acute toxicity related to irradiation such as lung and skin
Secondary Outcome Measures
acute radiation-induced toxicity assessed by CTCAE v4.0
acute toxicity related to skin and lung
local-regional recurrence
Disease free survival
Overall survival Over survival
Late complications
cosmetic effect measured by Harvard 4 scale evaluation system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02617043
Brief Title
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
Acronym
HF-WBI-SIB
Official Title
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, hypofractionated whole breast irradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HF-WBI
Arm Type
Experimental
Arm Description
Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.
Intervention Type
Radiation
Intervention Name(s)
hypofractionated whole breast irradiation with simultaneously integrated boost
Intervention Description
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed
Primary Outcome Measure Information:
Title
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
Description
acute toxicity related to irradiation such as lung and skin
Time Frame
2 year
Secondary Outcome Measure Information:
Title
acute radiation-induced toxicity assessed by CTCAE v4.0
Description
acute toxicity related to skin and lung
Time Frame
during radiotherapy; 3months; 6 months
Title
local-regional recurrence
Time Frame
5 years
Title
Disease free survival
Time Frame
5 years
Title
Overall survival Over survival
Time Frame
5 years
Title
Late complications
Time Frame
1,2,3,4,5years
Title
cosmetic effect measured by Harvard 4 scale evaluation system
Time Frame
2,3,4,5years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Yu, MD
Phone
+86 13817893133
Email
stephanieyxl@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoli Yu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Yu, MD,PhD
Phone
+86 13817893133
Email
stephanieyxl@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jurui Luo, MD
Phone
+86 13162996951
Email
juruiluo@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
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