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

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ClinicalTrials.gov Identifier: NCT02389673

Recruitment Status : Recruiting

First Posted : March 17, 2015

Last Update Posted : March 17, 2015

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Liao Ning, Guangdong Academy of Medical Sciences

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.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Device: Intraoperative Radiotherapy	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	222 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer
Study Start Date :	October 2014
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	June 2026

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Without Radiotherapy Patients just accept breast-conversing surgery without radiotherapy.
Experimental: Intraoperative Radiotherapy Boost with 20 Gy during BCS, EBRT with 46-50 Gy	Device: Intraoperative Radiotherapy Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Outcome Measures

Primary Outcome Measures :

ipsilateral breast tumor recurrence rate after surgery within five years [ Time Frame: Within 5 years after surgery ]
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 [ Time Frame: Within 5 years after surgery ]
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 [ Time Frame: Within ten years after surgery ]
After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389673

Contacts


Contact: Liao Ning, MD,PhD	+86 83827812

Locations


China, Guangdong
Guangdong Academy of Medical Sciences	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wen L Zhu 13763316144 dearecho@msn.com

Sponsors and Collaborators

Liao Ning

Investigators


Study Director:	Liao Ning, MD,PhD	Guangdong Academy of Medical Sciences

More Information


Responsible Party:	Liao Ning, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT02389673 History of Changes
Other Study ID Numbers:	GGHBCRG-IORT-DCIS
First Posted:	March 17, 2015 Key Record Dates
Last Update Posted:	March 17, 2015
Last Verified:	March 2015

Keywords provided by Liao Ning, Guangdong Academy of Medical Sciences:


Intermediate and high grade ductal carcinoma in situ （DCIS）

Additional relevant MeSH terms:


Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Breast Carcinoma In Situ Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary

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