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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
Sponsor:
Information provided by (Responsible Party):
Liao Ning, Guangdong Academy of Medical Sciences

Study Description
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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
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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

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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
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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
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Contact: Liao Ning, MD,PhD +86 83827812

Locations
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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
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Study Director: Liao Ning, MD,PhD Guangdong Academy of Medical Sciences
More Information
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Responsible Party: Liao Ning, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02389673    
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:
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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