Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Device: Intraoperative Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without Radiotherapy<br>Patients just accept breast-conversing surgery without radiotherapy. | |
| Experimental: Intraoperative Radiotherapy<br>Boost with 20 Gy during BCS, EBRT with 46-50 Gy | Device: Intraoperative Radiotherapy<br>* Boost with 20 Gy during BCS, EBRT with 46-50 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ipsilateral breast tumor recurrence rate after surgery within five years | Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure | Within 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival after surgery within five years | Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure. | Within 5 years after surgery | 
| Overall survival after surgery within ten years | After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure. | Within ten years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermediate and high grade ductal carcinoma in situ （DCIS）