search
Back to results

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

Primary Purpose

Breast Neoplasms

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative Radiotherapy
Whole breast radiation
Sponsored by
Liao Ning
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intraoperative Radiotherapy

whole breast radiation

Arm Description

Boost with 20 Gy during BCS, EBRT with 46-50 Gy

WRT:whole breast radiation after BCS 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
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.

Secondary Outcome Measures

Overall survival after surgery within ten years
After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Full Information

First Posted
March 10, 2015
Last Updated
March 10, 2015
Sponsor
Liao Ning
search

1. Study Identification

Unique Protocol Identification Number
NCT02389699
Brief Title
Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Ductal Carcinoma in Situ
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2024 (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
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.

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
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative Radiotherapy
Arm Type
Experimental
Arm Description
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Arm Title
whole breast radiation
Arm Type
Active Comparator
Arm Description
WRT:whole breast radiation after BCS with 46-50 Gy
Intervention Type
Radiation
Intervention Name(s)
Intraoperative Radiotherapy
Intervention Description
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Intervention Type
Radiation
Intervention Name(s)
Whole breast radiation
Intervention Description
whole breast radiation after BCS 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
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
Secondary Outcome Measure Information:
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 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
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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs