Back to resultsIntra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Intermediate and high grade ductal carcinoma in situ （DCIS）
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
Sites / Locations
- Guangdong Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Without Radiotherapy
Intraoperative Radiotherapy
Arm Description
Patients just accept breast-conversing surgery without radiotherapy.
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Overall survival after surgery within ten years
After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02389673
Brief Title
Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
Official Title
Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liao Ning
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Intermediate and high grade ductal carcinoma in situ （DCIS）
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Without Radiotherapy
Arm Type
No Intervention
Arm Description
Patients just accept breast-conversing surgery without radiotherapy.
Arm Title
Intraoperative Radiotherapy
Arm Type
Experimental
Arm Description
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Intervention Type
Device
Intervention Name(s)
Intraoperative Radiotherapy
Intervention Description
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Primary Outcome Measure Information:
Title
ipsilateral breast tumor recurrence rate after surgery within five years
Description
Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure
Time Frame
Within 5 years after surgery
Secondary Outcome Measure Information:
Title
Disease free survival after surgery within five years
Description
Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure.
Time Frame
Within 5 years after surgery
Title
Overall survival after surgery within ten years
Description
After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.
Time Frame
Within ten years after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liao Ning, MD,PhD
Phone
+86 83827812
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liao Ning, MD,PhD
Organizational Affiliation
Guangdong Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong Academy of Medical Sciences
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen L Zhu
Phone
13763316144
Email
dearecho@msn.com
12. IPD Sharing Statement
Learn more about this trial
Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
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