Comparison of the Efficacy of Intra-operative Radiation Therapy After Conserving Surgery With Post-operative Whole Breast Radiotherapy for Women With Ductal Carcinoma in Situ
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Liao Ning
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- ipsilateral breast tumor recurrence rate after surgery within five years
- Last Updated
- 11 years ago
Overview
Brief Summary
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 compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high 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
- •Intermediate or high grade ductal carcinoma in situ
- •Informed consent
Exclusion Criteria
- •No informed consent
- •Tumor size \> 3,5 cm
- •Low 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
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.
Secondary Outcomes
- Overall survival after surgery within ten years(Within ten years after surgery)