Breast Neoplasms
Conditions
Keywords
Intermediate and high grade ductal carcinoma in situ （DCIS）
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.
Interventions
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Sponsors
Liao Ning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ipsilateral breast tumor recurrence rate after surgery within five years | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival after surgery within five years | 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 | Within ten years after surgery | After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure. |
Countries
China
Contacts
Primary ContactLiao Ning, MD,PhD
Outcome results
None listed