Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer
1 other identifier
interventional
222
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMarch 17, 2015
March 1, 2015
4.7 years
March 10, 2015
March 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Disease free survival after surgery within five years
Within 5 years after surgery
Overall survival after surgery within ten years
Within ten years after surgery
Study Arms (2)
Without Radiotherapy
NO INTERVENTIONPatients just accept breast-conversing surgery without radiotherapy.
Intraoperative Radiotherapy
EXPERIMENTALBoost with 20 Gy during BCS, EBRT with 46-50 Gy
Interventions
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No informed consent
- Tumor size \> 5 cm
- Intermediate or high grade ductal carcinoma in situ
- Invasive carcinoma
- No indication for a boost
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liao Ninglead
Study Sites (1)
Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liao Ning, MD,PhD
Guangdong Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Guangdong Academy of Medical Sciences
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
October 1, 2014
Primary Completion
June 1, 2019
Study Completion (Estimated)
June 1, 2026
Last Updated
March 17, 2015
Record last verified: 2015-03