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Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
This study is currently recruiting participants.
Verified March 2015 by Liao Ning, Guangdong Academy of Medical Sciences
Sponsor:
Liao Ning
Information provided by (Responsible Party):
Liao Ning, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02389673
First received: March 10, 2015
Last updated: NA
Last verified: March 2015
History: No changes posted
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Purpose
Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.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.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.
| Condition | Intervention |
|---|---|
| Breast Neoplasms | Device: Intraoperative Radiotherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Further study details as provided by Liao Ning, Guangdong Academy of Medical Sciences:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 222 |
| Study Start Date: | October 2014 |
| Estimated Study Completion Date: | June 2026 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Without Radiotherapy
Patients just accept breast-conversing surgery without radiotherapy.
|
|
|
Experimental: Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
|
Device: Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
|
Detailed Description:
Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02389673
Please refer to this study by its ClinicalTrials.gov identifier: NCT02389673
Contacts
| Contact: Liao Ning, MD,PhD | +86 83827812 |
Locations
| China, Guangdong | |
| Guangdong Academy of Medical Sciences | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: Wen L Zhu 13763316144 dearecho@msn.com | |
Sponsors and Collaborators
Liao Ning
Investigators
| Study Director: | Liao Ning, MD,PhD | Guangdong Academy of Medical Sciences |
More Information
| Responsible Party: | Liao Ning, Guangdong Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT02389673 History of Changes |
| Other Study ID Numbers: |
GGHBCRG-IORT-DCIS |
| Study First Received: | March 10, 2015 |
| Last Updated: | March 10, 2015 |
Keywords provided by Liao Ning, Guangdong Academy of Medical Sciences:
|
Intermediate and high grade ductal carcinoma in situ （DCIS） |
Additional relevant MeSH terms:
|
Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on June 23, 2017