Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
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ClinicalTrials.gov Identifier: NCT02389673 |
Recruitment Status :
Recruiting
First Posted : March 17, 2015
Last Update Posted : March 17, 2015
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Condition or disease | Intervention/treatment | Phase |
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Breast Neoplasms | Device: Intraoperative Radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer |
Study Start Date : | October 2014 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | June 2026 |

Arm | Intervention/treatment |
---|---|
No Intervention: Without Radiotherapy
Patients just accept breast-conversing surgery without radiotherapy.
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Experimental: Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
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Device: Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy |
- 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Tumor diameter < 5 cm
- 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
Exclusion Criteria:
- No informed consent
- Tumor size > 5 cm
- Intermediate or high grade ductal carcinoma in situ
- Invasive carcinoma
- No indication for a boost

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): NCT02389673
Contact: Liao Ning, MD,PhD | +86 83827812 |
China, Guangdong | |
Guangdong Academy of Medical Sciences | Recruiting |
Guangzhou, Guangdong, China, 510080 | |
Contact: Wen L Zhu 13763316144 dearecho@msn.com |
Study Director: | Liao Ning, MD,PhD | Guangdong Academy of Medical Sciences |
Responsible Party: | Liao Ning, Guangdong Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT02389673 |
Other Study ID Numbers: |
GGHBCRG-IORT-DCIS |
First Posted: | March 17, 2015 Key Record Dates |
Last Update Posted: | March 17, 2015 |
Last Verified: | March 2015 |
Intermediate and high grade ductal carcinoma in situ (DCIS) |
Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Breast Carcinoma In Situ Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |