Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
HF-WBI-SIB
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 2, 2017
May 1, 2017
2.7 years
November 19, 2015
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
acute radiation-induced toxicity assessed by CTCAE v4.0
during radiotherapy; 3months; 6 months
local-regional recurrence
5 years
Disease free survival
5 years
Overall survival Over survival
5 years
Late complications
1,2,3,4,5years
- +1 more secondary outcomes
Study Arms (1)
HF-WBI
EXPERIMENTALHypofractionated 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.
Interventions
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed
Eligibility Criteria
You may qualify if:
- Female
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoli Yu, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of department of radiation oncology
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 30, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 2, 2017
Record last verified: 2017-05