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

Not Applicable

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Device: Intraoperative Radiotherapy

• Registration Number: NCT02389673
• Lead Sponsor: Liao Ning

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.

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 Timeline

• Study Start: 2014-10
• Status Verified: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Study First Posted: 2015-03-17
• Last Update Posted: 2015-03-17
• Primary Completion: 2019-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative Radiotherapy	Intraoperative Radiotherapy	Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Guangdong Academy of Medical Sciences; 🇨🇳 Guangzhou, Guangdong, China