Intra-operative Radiotherapy For Breast Cancer Women After NSM
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|ClinicalTrials.gov Identifier: NCT02389686|
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2024|
No Intervention: Without Radiotherapy
Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
Experimental: Intraoperative Radiotherapy
Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).
Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Boost with 16 Gy during NSM for nipple-areola complex (NAC)
- 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
- Disease free survival after surgery within five years [ Time Frame: Within 5 years after surgery ]Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure.
- Overall survival after surgery within ten years [ Time Frame: Within ten years after surgery ]After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389686
|Contact: Liao Ning, MD,PhD||+86 83827812|
|Guangdong Academy of Medical Sciences||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Wen LingZhu 13763316144 email@example.com|
|Study Director:||Liao Ning, MD,PhD||Guangdong Academy of Medical Sciences|