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

This study is currently recruiting participants.
Verified March 2015 by Liao Ning, Guangdong Academy of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02389673
First Posted: March 17, 2015
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Liao Ning, Guangdong Academy of Medical Sciences
  Purpose
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 Intervention
Breast Neoplasms Device: Intraoperative Radiotherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Liao Ning, Guangdong Academy of Medical Sciences:

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.


Estimated Enrollment: 222
Study Start Date: October 2014
Estimated Study Completion Date: June 2026
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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 Submitted: March 10, 2015
First Posted: March 17, 2015
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