Breast CancerPhase 2HF-WBI-SIBNCT02617043
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
A Phase 2 study testing hypofractionated whole breast irradiation with simultaneously integrated boost in people with Breast Cancer, run by Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- hypofractionated whole breast irradiation with simultaneously integrated boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaoli Yu, MD,PhD, +86 13817893133, stephanieyxl@hotmail.com
Jurui Luo, MD, +86 13162996951, juruiluo@hotmail.com
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- hypofractionated whole breast irradiation with simultaneously integrated boost
- Keywords
- breast cancer, hypofractionated whole breast irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated whole breast irradiation with simultaneously integrated boostRadiation
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed
| Study group | Role | What they receive |
|---|---|---|
| HF-WBI | Experimental | 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. Receives: Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
acute toxicity related to irradiation such as lung and skin
Measured: 2 year
Secondary outcomes (6)
acute radiation-induced toxicity assessed by CTCAE v4.0
acute toxicity related to skin and lung
Measured: during radiotherapy; 3months; 6 months
local-regional recurrence
Measured: 5 years
Disease free survival
Measured: 5 years
Overall survival Over survival
Measured: 5 years
Late complications
Measured: 1,2,3,4,5years
cosmetic effect measured by Harvard 4 scale evaluation system
Measured: 2,3,4,5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
- Investigators
- Xiaoli Yu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617043
- Sponsor's protocol ID
- FDRT-BC001
- Acronym
- HF-WBI-SIB
- Status last verified
- May 2017
- First submitted
- 19 Nov 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
- ClinicalTrials.gov ID
- NCT02617043
- Acronym / sponsor ID
- HF-WBI-SIB / FDRT-BC001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, hypofractionated whole breast irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF-WBI | Experimental | Radiation: hypofractionated whole breast irradiation with simultaneously integrated boostHypofractionated 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypofractionated whole breast irradiation with simultaneously integrated boostdeliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed | Radiation | HF-WBI |
Primary outcome
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
Time frame: 2 year
acute toxicity related to irradiation such as lung and skin
6 secondary outcomes
acute radiation-induced toxicity assessed by CTCAE v4.0
Time frame: during radiotherapy; 3months; 6 months
local-regional recurrence
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival Over survival
Time frame: 5 years
Late complications
Time frame: 1,2,3,4,5years
cosmetic effect measured by Harvard 4 scale evaluation system
Time frame: 2,3,4,5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoli Yu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypofractionated whole breast irradiation with simultaneously integrated boost in people with Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Yu, MD (+86 13817893133, stephanieyxl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0 (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.