Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Ductal Carcinoma in Situ

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Radiation: Intraoperative Radiotherapy
* Radiation: Whole breast radiation


Participation Criteria
=================
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

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative Radiotherapy<br>Boost with 20 Gy during BCS, EBRT with 46-50 Gy | Radiation: Intraoperative Radiotherapy<br>* Boost with 20 Gy during BCS, EBRT with 46-50 Gy<br>|
| Active Comparator: whole breast radiation<br>WRT:whole breast radiation after BCS with 46-50 Gy | Radiation: Whole breast radiation<br>* whole breast radiation after BCS with 46-50 Gy<br>|

What is the study measuring?
-----------------
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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermediate and high grade ductal carcinoma in situ （DCIS）