Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Ductal Carcinoma in Situ

Not Applicable

• Conditions: Breast Neoplasms
• Interventions: Radiation: Intraoperative Radiotherapy; Radiation: Whole breast radiation

• Registration Number: NCT02389699
• Lead Sponsor: Liao Ning

Brief Summary

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 compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• 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: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• Tumor diameter < 5 cm
• Intermediate or high grade ductal carcinoma in situ
• Informed consent

Exclusion Criteria

• No informed consent
• Tumor size > 3,5 cm
• Low 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
whole breast radiation	Whole breast radiation	WRT:whole breast radiation after BCS 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
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.

Secondary Outcome Measures

Name	Time	Method
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