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

Overview

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.

Full Title of Study: “Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2019

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.

Interventions

  • Device: Intraoperative Radiotherapy
    • Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Liao Ning
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Liao Ning, Guangdong Academy of Medical Sciences – Guangdong Academy of Medical Sciences
  • Overall Official(s)
    • Liao Ning, MD,PhD, Study Director, Guangdong Academy of Medical Sciences
  • Overall Contact(s)
    • Liao Ning, MD,PhD, +86 83827812

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