Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Liao Ning
- Enrollment
- 222
- Locations
- 1
- Primary Endpoint
- ipsilateral breast tumor recurrence rate after surgery within five years
- Status
- Recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
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.
Investigators
Liao Ning
Guangdong Academy of Medical Sciences
Guangdong Academy of Medical Sciences
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Disease free survival after surgery within five years(Within 5 years after surgery)
- Overall survival after surgery within ten years(Within ten years after surgery)