Breast NeoplasmsNCT02389686
Intra-operative Radiotherapy For Breast Cancer Women After NSM
A study testing INTRABEAM (Carl Zeiss, Oberkochen, Germany) in people with Breast Neoplasms, run by Liao Ning at 1 site in China.
Trial summary
The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. Read more about this study
- Who is it for?
- Ages 17 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- INTRABEAM (Carl Zeiss, Oberkochen, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2024
- Phase
- Interventional
- 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 17 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tumor diameter ≤3 cm
- Tumor from the papilla>2cm
- Low grade ductal carcinoma in situ
- Candidate for breast-conserving surgery
- Must have undergone lumpectomy with negative margins or minimal margin involvement
- Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
- No evidence of metastatic disease
- Informed consent
Who cannot join
- No informed consent
- Tumor size > 3 cm
- Tumor from the papilla≤2cm
- Intermediate or high grade ductal carcinoma in situ
- Invasive carcinoma
- No indication for a boost
Trial locations and contacts
1 site in 1 country.
Liao Ning, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Wen LingZhu, 13763316144, dearecho@msn.com
About this study
Official title: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy
The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.
Read the detailed description
Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.
- Conditions
- Breast Neoplasms
- Being tested
- INTRABEAM (Carl Zeiss, Oberkochen, Germany)
- Keywords
- Ductal carcinoma in situ （DCIS）, Nipple-sparing mastectomy (NSM), Intraoperative radiotherapy (IORT), INTRABEAM
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTRABEAM (Carl Zeiss, Oberkochen, Germany)Device
Boost with 16 Gy during NSM for nipple-areola complex (NAC)
| Study group | Role | What they receive |
|---|---|---|
| Without Radiotherapy | No intervention | Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy. |
| Intraoperative Radiotherapy | Experimental | Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC). Receives: Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral breast tumor recurrence rate after surgery within five years
Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure
Measured: Within 5 years after surgery
Secondary outcomes (2)
Disease free survival after surgery within five years
Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure.
Measured: Within 5 years after surgery
Overall survival after surgery within ten years
After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.
Measured: Within ten years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liao Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liao Ning, Guangdong Academy of Medical Sciences
- Investigators
- Liao Ning, MD,PhD, Study director, Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389686
- Sponsor's protocol ID
- GGHBCRG-IORT-NSM
- Status last verified
- Mar 2015
- First submitted
- 10 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy
- ClinicalTrials.gov ID
- NCT02389686
- Acronym / sponsor ID
- GGHBCRG-IORT-NSM
- Conditions
- Breast Neoplasms
- Keywords
- Ductal carcinoma in situ （DCIS）, Nipple-sparing mastectomy (NSM), Intraoperative radiotherapy (IORT), INTRABEAM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Liao NingUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 17 Mar 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 role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.
Detailed description
Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Radiotherapy | No intervention | –Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy. |
| Intraoperative Radiotherapy | Experimental | Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC). |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Tumor diameter ≤3 cm
- Tumor from the papilla>2cm
- Low grade ductal carcinoma in situ
- Candidate for breast-conserving surgery
- Must have undergone lumpectomy with negative margins or minimal margin involvement
Key exclusion criteria (6 listed)
- No informed consent
- Tumor size > 3 cm
- Tumor from the papilla≤2cm
- Intermediate or high grade ductal carcinoma in situ
- Invasive carcinoma
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 |
|---|---|---|
| INTRABEAM (Carl Zeiss, Oberkochen, Germany)Boost with 16 Gy during NSM for nipple-areola complex (NAC) | Device | Intraoperative Radiotherapy |
Primary outcome
Ipsilateral breast tumor recurrence rate after surgery within five years
Time frame: Within 5 years after surgery
Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure
2 secondary outcomes
Disease free survival after surgery within five years
Time frame: Within 5 years after surgery
Overall survival after surgery within ten years
Time frame: Within ten years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Liao Ning, MD,PhD contact
Liao Ning, MD,PhD study director
Guangdong Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTRABEAM (Carl Zeiss, Oberkochen, Germany) in people with Breast Neoplasms, run by Liao Ning 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 6 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 17 Mar 2015. 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.
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 Liao Ning, MD,PhD (+86 83827812), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral breast tumor recurrence rate after surgery within five years (time frame: Within 5 years after surgery). 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 17 Mar 2015.