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

Sponsor

Liao Ning (Other)

Overall Status

Recruiting

CT.gov ID

NCT02389673

Collaborator

(none)

222

Enrollment

Location

Arms

140

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 1, 2026

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

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 [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 [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 [Within ten years after surgery]
After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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